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Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients

NCT03486600 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2018-04-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Hany V Zaki, MD · Anesthesia and Surgical Intensive Care Department, Faculty of Medicine -Ain Shams University

  • Sherif MS Mowafy, MD · Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University

  • Nasr MA SeifElnasr, MD · Anesthesia and Surgical intensive care Department, Faculty of Medicine - Cairo University

  • Ahmed H Bakeer, MD · Anesthesia and pain relief Department, National Cancer Institute - Cairo University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-10-01
Completion
2019-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03486600 on ClinicalTrials.gov