TraumaNCT03486600
Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 in Trauma Patients
A study testing Fluid Resuscitation in people with Trauma, run by Zagazig University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma
- What is being tested?
- Fluid Resuscitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Trauma patients in hemorrhagic shock
- Expected delay in blood and blood products transfusion for more than 40 minutes.
Who cannot join
- Known chronic renal disease
- Known chronic liver disease
- Known coagulopathy
- Known allergy to Hydroxyethyl starch
- Known pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety of Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 on Blood Coagulation and Renal Functions in Trauma Patients: Multicenter Clinical Trial
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.
Read the 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
- Being tested
- Fluid Resuscitation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid ResuscitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fluid Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 7 days
Secondary outcomes (3)
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
Measured: 30 days
30-day mortality
the effect of HES 130/0.4 resuscitation on patient mortality
Measured: 30 days
length of stay in the hospital.
early fluid resuscitation with HES 130/0.4 may affect the length of stay in hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Hany V Zaki, MD, Study director, Anesthesia and Surgical Intensive Care Department, Faculty of Medicine -Ain Shams UniversitySherif MS Mowafy, MD, Principal investigator, Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig UniversityNasr MA SeifElnasr, MD, Principal investigator, Anesthesia and Surgical intensive care Department, Faculty of Medicine - Cairo UniversityAhmed H Bakeer, MD, Principal investigator, Anesthesia and pain relief Department, National Cancer Institute - Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486600
- Sponsor's protocol ID
- 4410/11-3-2018
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 28058475(2) Jabaley C and Dudaryk R: Fluid Resuscitation for Trauma Patients: Crystalloids Versus Colloids. CurrAnesthesiol Rep 2014; 4:216-224.
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.
PubMed 27072503James 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.
PubMed 21857015Ding 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.
PubMed 28114128Masoumi 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.
PubMed 27738483
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Fluid Resuscitation With Hydroxyethyl Starch 130/0.4 on Blood Coagulation and Renal Functions in Trauma Patients: Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03486600
- Acronym / sponsor ID
- 4410/11-3-2018
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| fluid resuscitation | Other | Other: Fluid ResuscitationPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Trauma patients in hemorrhagic shock
- Expected delay in blood and blood products transfusion for more than 40 minutes.
Key exclusion criteria (5 listed)
- Known chronic renal disease
- Known chronic liver disease
- Known coagulopathy
- Known allergy to Hydroxyethyl starch
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid ResuscitationPatients 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 |
Primary outcome
Abnormal Coagulation Profile
Time frame: 7 days
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
Time frame: 7 days
acute kidney injury as defined by the RIFLE (Risk, Injury, Failure, Loss, End stage kidney disease) criteria depending on serum creatinine and urine output
3 secondary outcomes
Length of stay in the intensive care unit (ICU)
Time frame: 30 days
30-day mortality
Time frame: 30 days
length of stay in the hospital.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Background: PubMed 28058475Wise 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.
- Background(2) Jabaley C and Dudaryk R: Fluid Resuscitation for Trauma Patients: Crystalloids Versus Colloids. CurrAnesthesiol Rep 2014; 4:216-224.
- Background: PubMed 27072503Rossaint 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.
- Background: PubMed 21857015James 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.
- Background: PubMed 28114128Ding 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.
- Background: PubMed 27738483Masoumi 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.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hany V Zaki, MD study director
Anesthesia and Surgical Intensive Care Department, Faculty of Medicine -Ain Shams University
Sherif MS Mowafy, MD principal investigator
Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Nasr MA SeifElnasr, MD principal investigator
Anesthesia and Surgical intensive care Department, Faculty of Medicine - Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Resuscitation in people with Trauma, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif MS Mowafy, MD (01003523374 ext. 002, sherifmowafy2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal Coagulation Profile (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03486600, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.