scholarly journals Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S - Scandinavian Starch for Severe Sepsis/Septic Shock trial): Study protocol, design and rationale for a double-blinded, randomised clinical trial

Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Anders Perner ◽  
◽  
Nicolai Haase ◽  
Jørn Wetterslev ◽  
Anders Åneman ◽  
...  
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  

Abstract 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.


2008 ◽  
Vol 33 (Sup 1) ◽  
pp. e32
Author(s):  
M. P. Hendriks ◽  
C. J.M. de Weert ◽  
M. A.L. Pluim ◽  
H. P. Hu ◽  
M. M.J. Snoeck ◽  
...  

2008 ◽  
Vol 33 (Suppl 1) ◽  
pp. e32.1-e32
Author(s):  
M. P. Hendriks ◽  
C. J.M. de Weert ◽  
M. A.L. Pluim ◽  
H. P. Hu ◽  
M. M.J. Snoeck ◽  
...  

1987 ◽  
Vol 317 (11) ◽  
pp. 653-658 ◽  
Author(s):  
Roger C. Bone ◽  
Charles J. Fisher ◽  
Terry P. Clemmer ◽  
Gus J. Slotman ◽  
Craig A. Metz ◽  
...  

2021 ◽  
pp. 40-48
Author(s):  
Tinglan Zuo ◽  
Sergey Solyarik

The aim. Compare the hemodynamic effects and safety of infusion of the balanced crystalloid solution, sorbitol-based solution, and standard solution (0.9 % sodium chloride). Materials and methods. A prospective randomized clinical trial was carried out, the study included 68 adult patients, who had the active surgical infection, and were in a state of septic shock. A corresponding solution with a volume of 500 ml was used for resuscitation. Hemodynamic and other clinical and laboratory parameters were monitored. Results. There was no significant difference in mean arterial pressure (MAP) between the 3 groups before the 45th minute (p>0.05), from the 50th minute to 2 hours they were found only between the NS and Sorb groups (p <0.05). No statistically significant difference in heart rate (HR) was obtained in any measurement (p> 0.05). Cardiac output (CO) and oxygen delivery (DO2) did not differ until 35 min (p> 0.05) and up to 40 min (p> 0.05); after 40 min and 45 min, a significant difference was also found between the Sorb and NS groups (p <0.05). After infusion of a sorbitol-containing solution and a balanced polyionic solution, the acid-base state of the blood significantly improved. The applied dose of the sorbitol-containing solution was safe for renal function and blood clotting in septic shock in this study. But the applied balanced polyionic solution may be associated with a decrease in the number of platelets. Daily changes by APACHE II scores in each group were not statistically significant. The difference in 7-day and 28-day mortality between groups was not statistically significant (p>0.05). Conclusions. In our study, the balanced polyionic solution with 1.9 % sodium lactate and 6 % sorbitol was the most effective and safe infusion solution for the treatment of septic shock, it can be used as a supplement to balanced crystalloid solutions. When using a balanced polyionic solution (Ringer's acetate) with 0.07 % L-malonic acid, the platelet count should be monitored more often


BMJ Open ◽  
2016 ◽  
Vol 6 (7) ◽  
pp. e011856 ◽  
Author(s):  
Francisco Colomina-Climent ◽  
Carola Giménez-Esparza ◽  
Cristina Portillo-Requena ◽  
José Manuel Allegue-Gallego ◽  
María Galindo-Martínez ◽  
...  

2020 ◽  
Vol 2 (5) ◽  
pp. e260-e269 ◽  
Author(s):  
Eefje Hanna Martine van der Heijden ◽  
Sofie Liny Marie Blokland ◽  
Maarten Reinier Hillen ◽  
Ana Paula Pinheiro Lopes ◽  
Fréderique Marie van Vliet-Moret ◽  
...  

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