Sepsis and Septic Shock

Cataldo, Rita; Vennari, Marialuisa

doi:10.1007/978-88-470-2661-2_10

Cited by 1 publication

(2 citation statements)

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“…Fluids suitable for plasma volume replacement are either crystalloid solutions (composed of water and electrolytes) or colloid solutions (containing macromolecules dissolved in an electrolyte solution). Crystalloid solutions diffuse easily into the interstitial space (IS), especially in the case of capillary leakage, and may potentially cause tissue oedema [ 14 ]. In contrast, colloid solutions contain macromolecules that are unable to pass semipermeable biological membranes and exert colloid-osmotic pressure, retaining water into the intravascular space (IVS).…”

Section: Introductionmentioning

confidence: 99%

“…Several studies have shown that colloids remain in the IVS regardless of their molecular weight or the degree of capillary leakage [ 15 – 17 ]. Thus, it is postulated that the amount of fluid needed for plasma volume replacement is lower with colloid solutions than with crystalloid solutions, and consecutive studies may speculate that less fluid is needed to achieve HDS using this method [ 14 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Marx

Zacharowski

Ichai

et al. 2021

Trials

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Background Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. Methods This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. Discussion This study aims to generate evidence regarding which regimen—a gelatine-crystalloid regimen or a pure crystalloid regimen—is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. Trial registration The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466. Registered on 17 March 2016.

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Section: Introductionmentioning

confidence: 99%