Trial Outcomes & Findings for Vasopressin Versus Catecholamines for Cerebral Perfusion Pressure Control in Brain Injured Trauma Patients (NCT NCT00795366)

Results Overview

The number of hours that participants remained with intracranial pressure above 20 mmHg

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

The number of hours during the first 5 days of intracranial pressure monitoring

Results posted on

2014-12-12

Participant milestones
Measure	AVP, Arginine Vasopressin Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg	Standard Catecholamine Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
Overall Study STARTED	42	54
Overall Study COMPLETED	42	54
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	AVP, Arginine Vasopressin n=42 Participants Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg	Standard Catecholamine n=54 Participants Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.	Total n=96 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 16 • n=5 Participants	38 years STANDARD_DEVIATION 18 • n=7 Participants	39 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	43 Participants n=7 Participants	77 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	54 participants n=7 Participants	96 participants n=5 Participants
ISS (Injury Severity Score)	29 units on a scale STANDARD_DEVIATION 9 • n=5 Participants	28 units on a scale STANDARD_DEVIATION 10 • n=7 Participants	28 units on a scale STANDARD_DEVIATION 10 • n=5 Participants

Timeframe: The number of hours during the first 5 days of intracranial pressure monitoring

Population: Intent-to-Treat

The number of hours that participants remained with intracranial pressure above 20 mmHg

Outcome measures
Measure	AVP, Arginine Vasopressin n=42 Participants Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg	Standard Catecholamine n=54 Participants Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
Time ICP >20	1.7 Hours Standard Deviation 1.8	.9 Hours Standard Deviation 2.6

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	AVP, Arginine Vasopressin n=42 participants at risk Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg	Standard Catecholamine n=54 participants at risk Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
General disorders Death	14.3% 6/42 • Number of events 6 • 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.	11.1% 6/54 • Number of events 6 • 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 data not reported

University of Miami

Phone: 305-585-1178