Clinical trial NCT03486600: Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients
Official title: Safety of Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 on Blood Coagulation and Renal Functions in Trauma Patients: Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-04-03
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Abnormal Coagulation Profile
timeFrame: 7 days
measure: Development of acute kidney injury
timeFrame: 7 days
Secondary outcomes:
measure: Length of stay in the intensive care unit (ICU)
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: length of stay in the hospital.
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesia and Surgical Intensive Care Department, Faculty of Medicine -Ain Shams University
name: Hany V Zaki, MD
role: STUDY_DIRECTOR
affiliation: Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
name: Sherif MS Mowafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesia and Surgical intensive care Department, Faculty of Medicine - Cairo University
name: Nasr MA SeifElnasr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesia and pain relief Department, National Cancer Institute - Cairo University
name: Ahmed H Bakeer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wise R, Faurie M, Malbrain MLNG, Hodgson E. Strategies for Intravenous Fluid Resuscitation in Trauma Patients. World J Surg. 2017 May;41(5):1170-1183. doi: 10.1007/s00268-016-3865-7.
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citation: James MF, Michell WL, Joubert IA, Nicol AJ, Navsaria PH, Gillespie RS. Resuscitation with hydroxyethyl starch improves renal function and lactate clearance in penetrating trauma in a randomized controlled study: the FIRST trial (Fluids in Resuscitation of Severe Trauma). Br J Anaesth. 2011 Nov;107(5):693-702. doi: 10.1093/bja/aer229. Epub 2011 Aug 19.
citation: Ding X, Cheng Z, Qian Q. Intravenous Fluids and Acute Kidney Injury. Blood Purif. 2017;43(1-3):163-172. doi: 10.1159/000452702. Epub 2017 Jan 24.
citation: Masoumi K, Forouzan A, Darian AA, Rafaty Navaii A. Comparison of the Effectiveness of Hydroxyethyl Starch (Voluven) Solution With Normal Saline in Hemorrhagic Shock Treatment in Trauma. J Clin Med Res. 2016 Nov;8(11):815-818. doi: 10.14740/jocmr2702w. Epub 2016 Sep 29.