NCT03486600

Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

Safety of Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 on Blood Coagulation and Renal Functions in Trauma Patients: Multicenter Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 392 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Fluid therapy in trauma patients is considered one of the common challenges in daily practice. Both crystalloids and colloids can be used to maintain adequate blood volume and tissue perfusion but there is an ongoing debate as both of them could affect coagulation and renal function. The latest generation of the commercially available Hydroxy Ethyl Starch (HES) solutions was developed to improve pharmacokinetics and safety profile of HES, minimizing adverse effects such as impairment of blood coagulation or renal function. But data on early fluid resuscitation in trauma patients with these starches are limited and its safety on coagulation and renal function is still questioned.

Detailed description

Fluid resuscitation is a fundamental of the initial management and resuscitation of trauma patients to preserve or restore normovolemia, cardiac output, tissue perfusion, and correcting coagulopathy and acid-base balance during massive blood loss, yet fluid therapy in trauma patients is considered one of the common challenges in our daily practice with a lot of controversies and recommendations changing from using crystalloids, colloids, and/or packed red blood cells. Also, fluid availability which does not necessarily matches the best fluid needed for the patient impacts the physician choice of fluids especially when blood is not available.Both crystalloids and colloids can be used to maintain adequate blood volume and tissue perfusion. But both of them could affect coagulation and renal function. Both crystalloids and colloids decrease concentration of coagulation factors and number of platelets causing dilutional coagulopathy. Moreover, synthetic colloids impair polymerization of fibrin and platelet function, aggravating coagulopathic state. So, their use may therefore increase blood loss. As, all hydroxyethyl starch (HES) colloid solutions are excreted through the kidneys and other ways of excretion are negligible a lot of clinical trials have raised concerns about the renal safety of HES due to observed high frequency of acute kidney injury and high mortality rates in critically ill patients.These effects depend on the pharmacokinetic properties of the HES used, which determines the HES plasma concentrations over time, in vivo molecular weight (Mw), and maximum doses used. The latest generation of the commercially available HES solutions the medium-Mw starch, HES 130/0.4 (6%, Voluven®), was developed to improve pharmacokinetics and to improve the safety profile of HES, minimizing adverse effects such as impairment of blood coagulation or renal function.

Conditions

• Trauma

Interventions

Type	Name	Description
OTHER	Fluid Resuscitation	Patients will be evaluated and the bleeding site to be investigated and hemorrhagic shock confirmed and there is an expected delay in blood and blood products transfusion for more than 40 minutes. 6% HES 130/0.4 (Voluven®) will be administered intravenously to maintain or restore hemodynamic stability up to a maximum dose of 50 mL/kg body weight.

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-10-01
• Completion: 2019-01-01
• First posted: 2018-04-03
• Last updated: 2018-04-03