Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379522
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2006-09-21
Brief Title:
Vasopressin in Traumatic Hemorrhagic Shock Study
Sponsor:
Volker Wenzel
Organization:
Medical University Innsbruck
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial Assessing Arginine Vasopressin Versus Saline Placebo in Refractory Traumatic Hemorrhagic Shock Patients VITRIS-study
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present trial is therefore to assess effects of arginine vasopressin vs saline placebo on hospital admission rate primary end point as well as hemodynamic variables fluid resuscitation requirements and hospital discharge rate secondary study end points in presumed traumatic hemorrhagic shock patients with a systolic arterial blood pressure 90 mm Hg after 10 min of standard shock treatment Accordingly the study reflects an add-on design to standard traumatic shock therapy
The hypothesis is that both arginine vasopressin and saline placebo have comparable effects on hemodynamic variables fluid resuscitation requirements and hospital admission and discharge rate The alternative hypothesis is that arginine vasopressin has more beneficial effects on hemodynamic variables fluid resuscitation requirements and hospital admission and discharge rate than saline placebo
The hypothesis is that both arginine vasopressin and saline placebo have comparable effects on hemodynamic variables fluid resuscitation requirements and hospital admission and discharge rate The alternative hypothesis is that arginine vasopressin has more beneficial effects on hemodynamic variables fluid resuscitation requirements and hospital admission and discharge rate than saline placebo
Detailed Description:
The study will be designed as a multicenter randomized placebo-controlled clinical trial with blinded assessment of the outcome in a study network with helicopter emergency medical service units in Austria Germany Switzerland Italy Czech Republic and the Netherlands
The protocol information and consent procedure will be approved by the institutional review board of each participating center Since this is a study randomizing unconscious patients who are unable to give informed consent at the time of randomization 43a Emergency study the requirement of informed consent is planned to be waived in accordance with the ethical standards of national legislation in Germany Austria Switzerland Italy Czech Republic and the Netherlands and the guidelines for good clinical practice of the European Agency for the Evaluation of Medicinal products Depending on the patients outcome either the surviving patient or the patients family in case of death of the patient or in case that the patient survives but remains mentally handicapped will be informed about the trial see appendix for patient information sheet the protocol specifies that if there are any objections the patient will be withdrawn from the study
Treatment assignments of blinded study drugs will be randomly generated by computer in blocks of two with stratification according to center Before the start of the trial staff at participating centers will be informed about the rationale of the protocol and the study participating centers will be subsequently contacted and visited to ensure proper enrollment
The protocol information and consent procedure will be approved by the institutional review board of each participating center Since this is a study randomizing unconscious patients who are unable to give informed consent at the time of randomization 43a Emergency study the requirement of informed consent is planned to be waived in accordance with the ethical standards of national legislation in Germany Austria Switzerland Italy Czech Republic and the Netherlands and the guidelines for good clinical practice of the European Agency for the Evaluation of Medicinal products Depending on the patients outcome either the surviving patient or the patients family in case of death of the patient or in case that the patient survives but remains mentally handicapped will be informed about the trial see appendix for patient information sheet the protocol specifies that if there are any objections the patient will be withdrawn from the study
Treatment assignments of blinded study drugs will be randomly generated by computer in blocks of two with stratification according to center Before the start of the trial staff at participating centers will be informed about the rationale of the protocol and the study participating centers will be subsequently contacted and visited to ensure proper enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None