Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients
Primary Purpose
Trauma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid Resuscitation
Sponsored by
About this trial
This is an interventional supportive care trial for Trauma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
fluid resuscitation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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-day mortality
the effect of HES 130/0.4 resuscitation on patient mortality
length of stay in the hospital.
early fluid resuscitation with HES 130/0.4 may affect the length of stay in hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03486600
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
392 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fluid resuscitation
Arm Type
Other
Arm Description
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
Intervention Name(s)
Fluid Resuscitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Abnormal Coagulation Profile
Description
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.
Time Frame
7 days
Title
Development of acute kidney injury
Description
acute kidney injury as defined by the RIFLE (Risk, Injury, Failure, Loss, End stage kidney disease) criteria depending on serum creatinine and urine output
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Length of stay in the intensive care unit (ICU)
Description
early fluid resuscitation with HES 130/0.4 may affect the length of stay in ICU
Time Frame
30 days
Title
30-day mortality
Description
the effect of HES 130/0.4 resuscitation on patient mortality
Time Frame
30 days
Title
length of stay in the hospital.
Description
early fluid resuscitation with HES 130/0.4 may affect the length of stay in hospital
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif MS Mowafy, MD
Phone
01003523374
Ext
002
Email
sherifmowafy2012@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hany V Zaki, MD
Phone
01221107373
Ext
002
Email
drhany_zaki@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany V Zaki, MD
Organizational Affiliation
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine -Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherif MS Mowafy, MD
Organizational Affiliation
Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasr MA SeifElnasr, MD
Organizational Affiliation
Anesthesia and Surgical intensive care Department, Faculty of Medicine - Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed H Bakeer, MD
Organizational Affiliation
Anesthesia and pain relief Department, National Cancer Institute - Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD
IPD Sharing Time Frame
data will be available 6 months after publication
IPD Sharing Access Criteria
by contacting the study director
Citations:
PubMed Identifier
28058475
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.
Results Reference
background
Citation
(2) Jabaley C and Dudaryk R: Fluid Resuscitation for Trauma Patients: Crystalloids Versus Colloids. CurrAnesthesiol Rep 2014; 4:216-224.
Results Reference
background
PubMed Identifier
27072503
Citation
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.
Results Reference
background
PubMed Identifier
21857015
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.
Results Reference
background
PubMed Identifier
28114128
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.
Results Reference
background
PubMed Identifier
27738483
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.
Results Reference
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Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients
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