Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Trauma

Intervention / Treatment
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* Other: Fluid Resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma patients in hemorrhagic shock Expected delay in blood and blood products transfusion for more than 40 minutes. Exclusion Criteria: Known chronic renal disease Known chronic liver disease Known coagulopathy Known allergy to Hydroxyethyl starch Known pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Trauma patients of both sexes and diagnosed to be in hemorrhagic shock and there is an expected delay in blood and blood products transfusion for more than 40 minutes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fluid resuscitation<br>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. | Other: Fluid Resuscitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal Coagulation Profile | abnormal coagulation profile as indicated by prothrobin time, partial thromboplastin time, international standardization ratio, prothrombin concentration and fibrengen level. Samples were collected on day one after patient stabilization. | 7 days | 
| Development of acute kidney injury | acute kidney injury as defined by the RIFLE (Risk, Injury, Failure, Loss, End stage kidney disease) criteria depending on serum creatinine and urine output | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the intensive care unit (ICU) | early fluid resuscitation with HES 130/0.4 may affect the length of stay in ICU | 30 days | 
| 30-day mortality | the effect of HES 130/0.4 resuscitation on patient mortality | 30 days | 
| length of stay in the hospital. | early fluid resuscitation with HES 130/0.4 may affect the length of stay in hospital | 30 days |