Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03486600
• Other study ID #: 4410/11-3-2018
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2018
• Last updated: March 31, 2018
• Start date: April 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2018
• Source: Zagazig University
• Contact: Sherif MS Mowafy, MD
• Phone: 01003523374
• Email: sherifmowafy2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 392
• Est. completion date: January 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

References & Publications (6)

(2) Jabaley C and Dudaryk R: Fluid Resuscitation for Trauma Patients: Crystalloids Versus Colloids. CurrAnesthesiol Rep 2014; 4:216-224.

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. Review. — View 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. — View 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. Epub 2016 Sep 29. — View Citation

Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer EA, Ozier Y, Riddez L, Schultz A, Vincent JL, Spahn DR. The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition. Crit Care. 2016 Apr 12;20:100. doi: 10.1186/s13054-016-1265-x. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	30-day mortality	the effect of HES 130/0.4 resuscitation on patient mortality	30 days
Secondary	length of stay in the hospital.	early fluid resuscitation with HES 130/0.4 may affect the length of stay in hospital	30 days