Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

NCT ID: NCT03486600

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-01-01

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.

Conditions

Trauma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Fluid Resuscitation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sherif M. S. Mowafy

principl investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany V Zaki, MD

Role: STUDY_DIRECTOR

Anesthesia and Surgical Intensive Care Department, Faculty of Medicine -Ain Shams University

Sherif MS Mowafy, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University

Nasr MA SeifElnasr, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and Surgical intensive care Department, Faculty of Medicine - Cairo University

Ahmed H Bakeer, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and pain relief Department, National Cancer Institute - Cairo University

Central Contacts

Sherif MS Mowafy, MD

Role: CONTACT

sherifmowafy2012@gmail.com

01003523374 ext. 002

Hany V Zaki, MD

Role: CONTACT

drhany_zaki@yahoo.com

01221107373 ext. 002

References

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.

Reference Type: BACKGROUND

PMID: 28058475 (View on PubMed)

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

Reference Type: BACKGROUND

Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar 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.

Reference Type: BACKGROUND

PMID: 27072503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21857015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28114128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27738483 (View on PubMed)

Other Identifiers

4410/11-3-2018

Identifier Type: -

Identifier Source: org_study_id