Low Dose Vasopressin in Traumatic Shock

NCT00420407 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: 056-1502-090
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.

Conditions

Injuries; Shock, Traumatic

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of This Study Will be Day 30 Mortality.

  Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.

  30 days

Secondary Outcomes (1)

• Level of Vasopressin After Trauma.

  12 hours

Study Arms (2)

I

EXPERIMENTAL

Vasopressin

Drug: vasopressin

2

PLACEBO COMPARATOR

bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added

Drug: normal saline control

Interventions

normal saline control DRUG

no vasopressin added to bolus or 5 hour continuous infusion

2

vasopressin DRUG

vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:
• Patient is a male or female patient presumed to be at least 18 years of age;
• Patient has a systolic blood pressure \< 90 mmHg;
• Patient has clinical evidence of acute traumatic injury;
• Infusion of study drug must start within one hour following SBP (systolic blood pressure) \< 90 mmHg

You may not qualify if:

• A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:
• Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
• Patient has received greater than 4 liters fluid since time of injury;
• Patient is enrolled in another shock trial;
• Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
• Female patient is pregnant by report or suspicion;

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE. Impact of low-dose vasopressin on trauma outcome: prospective randomized study. World J Surg. 2011 Feb;35(2):430-9. doi: 10.1007/s00268-010-0875-8.

  PMID: 21161222 RESULT

Related Links

• Department of Surgery Web Page, Vasopressin presentation

MeSH Terms

Conditions

Wounds and Injuries; Shock, Traumatic

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Stephen Cohn, M.D.
• Organization: University of Texas Health Science Center at San Antonio

mccarthyj@uthscsa.edu

210-567-5724

Study Officials

• Stephen M. Cohn, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: February 1, 2011
• Last Updated: June 18, 2019
• Results First Posted: April 16, 2013

Record last verified: 2013-04

Locations

US (1)