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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 4  |  Issue : 4  |  Page : 195-202

Pulse index continuous cardiac output versus central venous pressure-based early goal-directed therapy for septic shock patients: a randomized trial


Department of Anaesthesia, Zagazig University Hospital, Zagazig, Egypt

Date of Submission20-Dec-2016
Date of Acceptance11-Apr-2017
Date of Web Publication11-Oct-2017

Correspondence Address:
Mohamed T Ghanem
Department of Anesthesia and Surgical Intensive Care, Zagazig University Hospital, Zagazig University, Zagazig
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/roaic.roaic_124_16

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  Abstract 

Background
Central venous pressure-based early goal-directed therapy (EGDT) is considered the gold standard in the management of septic shock. We compared this approach with pulse index continuous cardiac output (PiCCO)-based EGDT in a randomized controlled study.
Patients and methods
Eighty septic shock patients were randomly divided into the conventional survival sepsis bundle group using central venous and arterial catheters (group C, n=40), and the modified survival sepsis bundle group using central venous and PiCCO arterial thermistor catheters (group P, n=40). Primary outcome included mortality at 28 days after diagnosis of shock. Secondary outcomes included ICU stay, days on mechanical ventilation, and renal replacement therapy (RRT).
Results
In comparison with group C, group P showed a lower mortality with no statistical differences at 28 days after diagnosis of shock [15 (37.5%) patients in the P group vs. 21 (52.5%) patients in the C group; P=0.11]. The population in the C group showed longer duration on ventilation, which was statistically significant [6 (5.0–7.0) in the C group vs. 3 (2.0–3.0) in the P group; P<0.001]. Days on RRT and ICU stay were also statistically shorter in the P group [1 (0.0–2.0) in the P group vs. 4 (1.0–5.0) in the C control group; P<0.001 for duration on RRT and 5 (4.0–6.0) in the P group vs. 10 (6.0–16.0) in the C group; P<0.001 for ICU stay].
Conclusion
PiCCO-based EGDT produced lower ICU stay, and shorter duration of ventilation and RRT; however, it did not reduce mortality in septic shock patients when compared with the conventional central venous pressure-based approach.

Keywords: central venous pressure, early goal-directed therapy, pulse index continuous cardiac output, septic shock


How to cite this article:
Ghanem MT, Aly AA. Pulse index continuous cardiac output versus central venous pressure-based early goal-directed therapy for septic shock patients: a randomized trial. Res Opin Anesth Intensive Care 2017;4:195-202

How to cite this URL:
Ghanem MT, Aly AA. Pulse index continuous cardiac output versus central venous pressure-based early goal-directed therapy for septic shock patients: a randomized trial. Res Opin Anesth Intensive Care [serial online] 2017 [cited 2020 Jun 4];4:195-202. Available from: http://www.roaic.eg.net/text.asp?2017/4/4/195/216450


  Introduction Top


Septic shock is characterized by hypoperfusion due to infection that is commonly followed by end organ failure and high mortality [1]. Its pathophysiologic sequelae include vasoplegia, myocardial dysfunction, endothelial injury [2], and capillary leak that is responsible for fluid imbalance. A cornerstone of management is to avoid both hypovolemia and hypervolemia with their deleterious consequences [3].

Early goal-directed therapy (EGDT) by Rivers et al. [4] depends on central venous pressure (CVP), mean arterial pressure (MAP), and central venous oxygen saturation (ScvO2) as hemodynamic and perfusion guides for the administration of fluids, vasopressors, and/or inotropes. This approach has been found to improve mortality and morbidity and is proposed by the surviving sepsis campaign as a standard approach [5]. However, further studies demonstrated that this approach is not valid and principles of management might be doubtful [6],[7]. Moreover, a recent meta-analysis and systematic review found no survival superiority of this approach when compared with the conventional one; in addition, it was associated with a higher mortality when compared with other perfusion targets as early lactate clearance [8].

The pulse index continuous cardiac output (PiCCO) was considered as a minimally invasive all-inclusive device that provides a full picture of the patient’s hemodynamic profile as preload, contractility, and afterload [9]. However, its role has not been sufficiently explored in septic shock. Hence, we conducted this study to compare PiCCO and CVP-based EGDT for septic shock patients on the basis of the hypothesis that PiCCO-based management may provide a better clinical outcome.


  Patients and methods Top


This prospective randomized trial was conducted in a 25-bed emergency ICU in Zagazig University Hospital from the beginning of July 2014 to the end of June 2016. A total of 80 consecutive adult patients of both genders who met the clinical criteria of septic shock due to surgical cause within 24 h after admission to ICU were enrolled after being screened for eligibility ([Figure 1]). A written informed consent form was signed by patients or their kin, and approval was taken from the local Institutional Review Board. Exclusion criteria included patients with contraindications to arterial catheter insertion (e.g. coagulopathy), conditions likely to make PiCCO measurements inaccurate (intracardiac shunts, significant tricuspid or aortic regurgitation, unstable arrhythmias, and morbidly obese patients). Patients who were spontaneously breathing or those in whom surgical intervention was delayed for more than 6 h were also excluded from the study. Patients were randomly allocated using computer-generated random numbers into two equal groups; 40 patients were treated according to the conventional CVP-based EGDT in the first group (C group), and the remaining 40 patients were treated according to the PiCCO-based EGDT (P group) ([Figure 1]). Septic shock is defined as a systolic blood pressure of less than 90 mmHg or MAP less than 70 mmHg, or a systolic blood pressure decrease greater than 40 mmHg despite adequate fluid resuscitation [10]. We used the same ECG monitor (infinity κ with a PiCCO system ‘Pulsion technology’) for both arms.
Figure 1 Patients flow chart demonstrating the number of patients eligible for inclusion into the study, enrollment, randomization, follow-up, and analysis. CVP, central venous pressure; PiCCO, pulse index continuous cardiac output.

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Control intervention

For group C (CVP-based EGDT according to Rivers et al. [4]), central venous (preferably internal jugular or subclavian) and radial artery catheters were inserted in every patient. The hemodynamic and perfusion targets were CVP between 8 and 12 mmHg, MAP greater than 65 mmHg, and ScvO2 greater than 70%. If the CVP was less than 8 mmHg, a 500-ml bolus of crystalloid was infused over 15–30 min, aiming to achieve a CVP of 8–12 mmHg; the bolus could be repeated if the target was not reached. If CVP ranged from 8 to 12 mmHg or exceeded 12 mmHg, we checked MAP. If MAP was less than 65 mmHg, norepinephrine was started at 0.05 µg/kg/min and titrated as needed, whereas if MAP exceeded 100 mmHg, nitroglycerin and/or furosemide could be administered at the discretion of the attending physician. Dobutamine was started as an inotropic support (starting dose: 5 µg/kg/min) if volume status and MAP were within target but the ScvO2 was less than 70% ([Figure 2]).
Figure 2 Central venous pressure (CVP)-based early goal-directed therapy algorithm. MAP, mean arterial pressure; ScvO2, central venous oxygen saturation.

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Experimental interventions

For the P group (PiCCO-based EGDT), a central venous catheter (preferably jugular or subclavian) and femoral thermistor-tipped arterial catheter were placed in every patient. The PiCCO system (Pulsion Medical Systems, Munich, Germany) is used within 2 h of enrollment; this monitor uses a single-thermal indicator technique. A 15–20 ml of normal saline at a temperature less than 8°C is injected into the most distal lumen of the central vein by the same person at the same speed, and various hemodynamic parameters can be obtained through analysis of variations in blood temperature taken by the temperature sensor of the arterial catheter. Pressure should yield results with less than 20% variation. At least three cold boluses are required for each calibration to obtain an acceptable precision. The calibration should be performed at least every 8 h, or following a major change in a patient’s clinical condition. Global end-diastolic volume (GEDV), which is the difference between the intrathoracic thermal volume and pulmonary thermal volume, represents the combined end-diastolic volumes of the four cardiac chambers. Intrathoracic blood volume (ITBV) represents volumes of the four cardiac chambers plus pulmonary vessels and is calculated as 1.25×GEDV. Extravascular lung water (EVLW) is the difference between the intrathoracic thermal volume and ITBV, and represents the water content in the lungs. Global ejection fraction (GEF) is the percentage of total blood expelled from the heart at every beat to the total amount of blood estimated to be present just before ventricular systole and is calculated as 4×stroke volume/GEDV. The absolute EVLW, ITBV, and GEDV values were indexed to predicted body weight and provided as Extravascular lung water index (EVLWI), Intrathoracic blood volume index (ITBVI), and Global end diastolic volume index (GEDVI), respectively. The monitor can also automatically calculate the stroke volume variability (SVV), which is a dynamic parameter of fluid responsiveness and reflects the sensitivity of the heart to the cyclic changes in cardiac preload induced by mechanical ventilation (MV). We recorded the SVV value at the time of GEDVI measurement.

The aim is to maintain an ITBVI 850–1000 ml/m2 with SVV less than 13%, and EVLWI less than 10 ml/kg. If ITBVI was less than 850 ml/m2, a 500-ml bolus of crystalloid was infused over 15–30 min, aiming to achieve an ITBVI 850–1000 ml/m2; the bolus could be repeated if the target was not reached. If ITBVI was 850–1000 ml/m2, SVV was checked and crystalloids were administered and may be repeated as long as it was less than 13% and EVLWI was less than 10 ml/kg. If EVLWI was greater than 10 ml/kg and the patient was still in need of fluid resuscitation, we chose albumin as a resuscitation fluid and considered diuretic administration. If ITBVI was within normal range with accepted SVV and EVLWI or exceeded the normal range, MAP was checked. If MAP was less than 65 mmHg, norepinephrine was started at 0.05 µg/kg/min and was titrated as needed. If MAP exceeded 100 mmHg, nitroglycerin and/or furosemide were/was administered at the discretion of the attending physician. Dobutamine was initiated at a dose of 5µg/kg/min if GEF was less than 25% ([Figure 3]). The PiCCO system was removed if the patient was clinically stable for 48 h as determined by attending physicians. This system was maintained for a maximum of 10 days. If catheter-related blood stream infection was suspected, the central venous catheter was removed and sent for microbiological study, and the catheter was exchanged for a new one.
Figure 3 Pulse index continuous cardiac output −based early goal-directed therapy algorithm. GEF, global ejection fraction; MAP, mean arterial pressure.

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In both groups, the treatment algorithms were a cycle that could be repeated. In the absence of shock, strenuous fluid boluses were not given for volume expansion. There was also no prespecified time interval for the measurement of hemodynamic parameters, which was at the discretion of the treating physician. All patients in the study received antibiotics according to the local antibiogram after doing a blood culture. They also received steroids as long as the norepinephrine dose exceeded 0.2 µg/kg/min.

Outcomes

Primary outcome measures included mortality at 28 days after diagnosis of shock. Secondary outcome measures included ICU stay (number of days from day 1 to day 28 that the patient spent in the ICU), ventilator days (number of days from day 1 to day 28 during which the patient was ventilator supported), and renal replacement therapy (RRT) days (number of days from day 1 to day 28 during which the patient received RRT). Tertiary outcome measures included changes of postresuscitation relevant parameters after 6 h resuscitation (blood lactate level, ScvO2, CVP, MAP, urine volume, and the total amount of fluids and vasopressors administered).

Statistical analysis

Data were collected throughout, including history, basic clinical examination, laboratory investigations, and the outcome measures were coded, entered, and analyzed using Microsoft Excel software (IBM SPSS Statistics V20.0.0; USA). Data were then imported into statistical package for the social sciences (SPSS, version 20.0) software for analysis. According to the type of data, qualitative data were represented as number and percentage, and quantitative data continue to be the group represented by median and interquartile ranges. Differences for significance were determined as follows: differences between frequencies (qualitative variables) and percentages in groups were compared by χ2 test, and differences between parametric quantitative independent groups were determined by the t test, and in nonparametric groups by the Mann–Whitney test. P value was set at less than 0.05 for significant results and less than 0.001 for a high significant result.


  Results Top


There was no statistically significant difference regarding patient characteristics between the two groups. Primary outcome in the form of 28 days mortality was not statistically significant between the study groups; however, it was lower in the interventional group [21 (52.5%) in conventional group vs. 15 (37.5%) in the PiCCO group; P=0.11). As regards the secondary outcome, the days on MV and RRT were statistically lower in the PiCCO group [3 days (2.0–3.0) vs. 6 days (5.0–7.0) in the C group for MV, and 1 day (0.0–2.0) vs. 4 days (1.0–5.0) in the control group for RRT; with a P<0.001for both]. However, the length of stay was significantly longer in the control group [10 days (6.0–16.0) vs. 5 days (4.0–6.0) in the PiCCO group; P<0.001]. After 6 h of resuscitation, the MAP showed no statistical difference between the study groups (66.51±5.83 mmHg in the C group vs. 66.28±6.29 mmHg in the P group; P=0.86). Urine output and lactate level were also comparable in the two groups [225 ml (110.0–290.0 ml) and 3.107±0.93 mmol/l in the control group vs. 250 ml (150.0–300.0 ml) and 3.04±0.97 mmol/l in the intervention groups, with a P=0.79 and 0.76, respectively]. In contrast, the CVP measurement showed significant difference between groups (9.74±1.77 mmHg in the C group vs. 8.51±1.53 mmHg in the P group; P=0. 002), whereas, the amount of fluids and vasopressors used were significantly higher in the CVP-based group [3051.25±604.7 ml and 2.5 mg (1.3–4.0 mg) vs. 1846.15±383.09 ml and 8 mg (7.0–10.0 mg) in the PiCCO-based group, respectively, with a P=0.001 for both] ([Table 1] and [Table 2]).
Table 1 Patient characteristics

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Table 2 Comparison of outcomes between pulse index continuous cardiac output and control groups

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  Discussion Top


Optimization of the volume status is of paramount importance for patients with septic shock; volume depletion results in tissue hypoperfusion and organ dysfunction, whereas volume overload leads to cardiac load and increased mortality [11]. The initial management in the EGDT protocol by Rivers et al. [4] was to rapidly expand the circulation on the basis of the absolute value of CVP. However, there is a lot of debate about the use of CVP as a preload indicator and the fact that not all hemodynamically unstable septic patients are fluid responsive cannot be overlooked [12],[13]; generally, ventricular preload cannot be represented by the central venous filling pressure due to inaccurate readings of pressure tracings [14], dissociation between the measured and the transmural pressures [15], and the variations in ventricular compliance [16]. Marik et al. [17] also showed in their systematic review that CVP should not be used to direct fluid management due to the inappropriate relation between CVP and blood volume. Specifically for those in septic shock, CVP could not represent the circulating volume or EVLW in one study [18]. Moreover, there were three large, international, multicenter, randomized trials (ProCESS, ARISE, and ProMISe) [19],[20],[21] that investigated the role of the CVP and ScvO2 as targets for therapy in patients with septic shock; they found no added benefit when compared with the conventional approaches. Glassford et al. [22] studied the hemodynamic effect of fluid boluses in patients with sepsis; they reported that MAP increased by about 8 mmHg immediately after fluid bolus and lasts only for one hour. Lammi et al. [23] also examined the physiological effect of 569 fluid boluses in 127 patients (most of them were septic patients) as a retrospective analysis of the FACTT trial [24]; they found that only 23% of patients were fluid responders with a small increase in the MAP and no change in urine output in the first four hours after the fluid infusion. Monge-Garcia et al. [25] found that 67% of patients were fluid responders, whereas only 44% were pressure responders while measuring the effects of a fluid bolus on arterial load in patients with septic shock. In addition, the allowed fluids for resuscitation in septic shock patients have poor ability to expand the circulation to the extent that only about 15% of the infusate remains in circulation after 3 h from starting infusion in one study [26] and 5% after only 1 h in other experimental studies [27],[28]. Therefore, other methods have been investigated to assess the preload, such as right ventricular end-diastolic volume evaluated by  Swan-Ganz catheter More Detailss [29], echocardiographic measurement of the left ventricular end diastolic area [30], and measurement of the ITBV using the thermodilution principle [31].

PiCCO is a relatively new minimally invasive hemodynamic modality that depends on the thermodilution technique and arterial pulse contour analysis. It continuously monitors parameters such as contractility, preload parameters such as ITBV, GEDV, EVLW, and systemic vascular resistance [32]. The efficacy of the PiCCO approach has been previously studied in terms of early changes in the physiological variables in the majority of the studies [33]; however, only few randomized trials investigated the impact of the PiCCO-based approach on mortality in patients with septic shock [34]. Moreover, GEDV has been known to be a valuable modality in determining cardiac preload than other filling pressures in patients with septic shock [35]. Furthermore, the inclusion of both GEDVI and EVLWI into the protocol of management has been shown to improve outcomes in certain patient populations [36].

In the present study, PiCCO-based fluid management produced a shorter duration of ventilation and RRT, with a lesser ICU stay and nonstatistical significant reduction in mortality at 28 days. We associated these results to the presence of an optimum monitoring device and early application of a tight protocol of management. Previous trials also found that improved patient core outcome was related directly to the presence of these two factors [37],[38]. Several trials found the association between improved outcome and the early application of hemodynamic support protocols in septic and postoperative patients [39],[40],[41]. In contrast, similar protocols had no beneficial effect and may even worsen outcome if applied later [42],[43]. Inconsistent with our findings, Trof et al. [44] showed that PiCCO-based fluid management failed to improve ventilator-free days, length of stay, and mortality of critically ill patients with septic shock. However, this may be explained by the nonbalanced randomization of their parameters.Fluid overload has been known to be associated with a higher incidence of acute respiratory distress syndrome [45], longer ICU and ventilator duration, worse outcome [46], and increased mortality in heterogeneous ICU populations [47]. However, net negative fluid balance was associated with decreased mortality for septic shock patients [48]. The measurement of EVLWI using the PiCCO system in the present study confirmed these findings, as it allowed the quantitative estimation of pulmonary edema and could direct management either to infuse more crystalloids, shift to albumin, or to administer diuretics.

Inotropic administration may be needed in septic shock patients and is proposed by the EGDT protocol if ScvO2 is less than 70 mmHg in an euvolemic patient with normal MAP. However, this approach is criticized by other authors; Marik et al. [49], found that there is no evidence that PRBCs or dobutamine really increase ScvO2. Moreover, ScvO2 in sepsis is frequently normal or increased. Puskarich et al. [50] also investigated 203 Emergency department (ED) patients in septic shock; they compared ScvO2 greater than 70 and lactate clearance and found no direct correlation. In the present study, we used the GEF in the intervention group rather than ScvO2 as an indicator for inotropic need to avoid these conflicts.

The concept of hemodynamic-guided restricted fluid resuscitation has been raised on the basis of the finding that CVP and ScvO2 are commonly inaccurate in septic shock patients. This concept consists of administering fluids only after assessment of the fluid responsiveness, early pressor administration, and evaluation of pumping function of the heart to guide inotropic support [51]. The use of the PiCCO-based management approach is considered to be even superior to this approach, as it directs precisely administering fluids either as crystalloids or albumin, pressor and/or inotropes infusion according to the data obtained from ITBVI, systemic vascular resistance, and GEF.

Because of the high cost of inserting the PiCCO catheter, the small sample size is considered the most important limitation to the present study. Other limitations of the study are mentioned below. First, we did not study the effect of PiCCO-based fluid management on long-term mortality as 90 days mortality. Second, we used rough values for hemodynamic variables; however, these values vary among different patients − for example, a higher value of ITBVI may be obtained in patients with left ventricular dysfunction, and EVLWI may reach up to 12 ml/kg in septic patients due to the increased pulmonary permeability. Third, we studied patients with sepsis of surgical etiology only, and the results might not be applicable to other types of sepsis. Last, it is difficult to be adherent to all of the items of the algorithmic approach all the time; for example, in patients with elevated EVLWI, we may not be able to administer diuretics if there is associated shock. Therefore, the authors recommend conducting a larger multicenter study involving other types of septic shock patients.

We concluded that the use of PiCCO hemodynamic monitoring in patients with septic shock limited ICU stay and the time spent on MV and RRT; however, it did not reduce mortality. It also produced more comprehensive derived physiological values, guiding an optimal approach for fluid resuscitation and appropriate selection of vasopressor and or inotropes.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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