Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

NCT03486600 | Unknown

• 1 other identifier: 4410/11-3-2018
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trauma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Length of stay in the intensive care unit (ICU)

  30 days

• 30-day mortality

  30 days

• length of stay in the hospital.

  30 days

Study Arms (1)

fluid resuscitation

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.

Other: Fluid Resuscitation

Interventions

Fluid Resuscitation 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.

fluid resuscitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Trauma patients in hemorrhagic shock
• Expected delay in blood and blood products transfusion for more than 40 minutes.

You may not qualify if:

• Known chronic renal disease
• Known chronic liver disease
• Known coagulopathy
• Known allergy to Hydroxyethyl starch
• Known pregnancy

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (6)

• 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.

  PMID: 28058475 BACKGROUND

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

  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.

  PMID: 27072503 BACKGROUND

• 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.

  PMID: 21857015 BACKGROUND

• 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.

  PMID: 28114128 BACKGROUND

• 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.

  PMID: 27738483 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Hany V Zaki, MD

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

  STUDY DIRECTOR

• Sherif MS Mowafy, MD

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

  PRINCIPAL INVESTIGATOR

• Nasr MA SeifElnasr, MD

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

  PRINCIPAL INVESTIGATOR

• Ahmed H Bakeer, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif MS Mowafy, MD

CONTACT

01003523374; sherifmowafy2012@gmail.com

Hany V Zaki, MD

CONTACT

01221107373; drhany_zaki@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principl investigator

Model Details: 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

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 3, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available 6 months after publication
• Access Criteria: by contacting the study director