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Vasopressin Versus Catecholamines for Cerebral Perfusion Pressure Control in Brain Injured Trauma Patients (AVP)

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ClinicalTrials.gov Identifier: NCT00795366
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Interventions Drug: arginine vasopressin
Drug: Standard catecholamine
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AVP, Arginine Vasopressin Standard Catecholamine
Hide Arm/Group Description Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
Period Title: Overall Study
Started 42 54
Completed 42 54
Not Completed 0 0
Arm/Group Title AVP, Arginine Vasopressin Standard Catecholamine Total
Hide Arm/Group Description Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg. Total of all reporting groups
Overall Number of Baseline Participants 42 54 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 54 participants 96 participants
40  (16) 38  (18) 39  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 54 participants 96 participants
Female
8
  19.0%
11
  20.4%
19
  19.8%
Male
34
  81.0%
43
  79.6%
77
  80.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 54 participants 96 participants
42 54 96
ISS (Injury Severity Score)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 42 participants 54 participants 96 participants
29  (9) 28  (10) 28  (10)
[1]
Measure Description: ISS is an anatomical scoring system that provides an overall score for patients with multiple injuries. Each injury is assigned an Abbreviated Injury Scale (AIS) score and is allocated to one of six body regions (Head, Face, Chest, Abdomen, Extremities (including Pelvis), External). Only the highest AIS score in each body region is used. The 3 most severely injured body regions have their score squared and added together to produce the ISS score. The ISS scores range from 1 to 75, being one the least severe and 75 the most severe trauma injury.
1.Primary Outcome
Title Time ICP >20
Hide Description The number of hours that participants remained with intracranial pressure above 20 mmHg
Time Frame The number of hours during the first 5 days of intracranial pressure monitoring
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title AVP, Arginine Vasopressin Standard Catecholamine
Hide Arm/Group Description:
Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
Overall Number of Participants Analyzed 42 54
Mean (Standard Deviation)
Unit of Measure: Hours
1.7  (1.8) .9  (2.6)
Time Frame Adverse events were collected during the primary study period as the first 5 days of intracranial pressure monitoring while outcome data was also collected from admission until discharge from the hospital.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AVP, Arginine Vasopressin Standard Catecholamine
Hide Arm/Group Description Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
All-Cause Mortality
AVP, Arginine Vasopressin Standard Catecholamine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AVP, Arginine Vasopressin Standard Catecholamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/42 (14.29%)      6/54 (11.11%)    
General disorders     
Death   6/42 (14.29%)  6 6/54 (11.11%)  6
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AVP, Arginine Vasopressin Standard Catecholamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/54 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kenneth Proctor, PhD, Professor of Surgery
Organization: University of Miami
Phone: 305-585-1178
EMail: kproctor@med.miami.edu
Layout table for additonal information
Responsible Party: Kenneth Proctor, University of Miami
ClinicalTrials.gov Identifier: NCT00795366     History of Changes
Other Study ID Numbers: 20060949
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: December 1, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014