NCT01555554

Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder

Terminated NA Last updated 22 July 2021

What this trial tests

NA trial testing Propranolol Hydrochloride in Post-traumatic Stress Disorder in 59 participants. Terminated before completion.

Timeline

1 May 2012

Primary endpoint
1 June 2018

1 June 2019

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	59
Start date	1 May 2012
Primary completion	1 June 2018
Estimated completion	1 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Propranolol Hydrochloride — full drug profile →
• Placebo

Conditions studied

• Post-traumatic Stress Disorder — all drugs for Post-traumatic Stress Disorder →

Sponsor

University of California, San Francisco

Who can join

40 and older, any sex, with Post-traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• ICU length of stay
  Time frame: Truncated at 30 days after admission to ICU
  Measured using patient medical records
• Hospital length of stay
  Time frame: Truncated at 30 days after admission to ICU
  Measured using patient medical records
• Postoperative delirium
  Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
  Measured using Confusion Assessment Method (CAM-CAM-ICU)
• Postoperative renal dysfunction
  Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
  Measured using Serum Creatinine laboratory values

Sponsor's own description

Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.

Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations.

This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.

The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for preventing delirium in hospitalised non-ICU patients.
   Siddiqi N, Harrison JK, Clegg A, Teale EA, et al · · 2016 · cited 248× · PMID 26967259 · DOI 10.1002/14651858.cd005563.pub3
2. Perioperative beta-blockers for preventing surgery-related mortality and morbidity in adults undergoing non-cardiac surgery.
   Blessberger H, Lewis SR, Pritchard MW, Fawcett LJ, et al · · 2019 · cited 29× · PMID 31556094 · DOI 10.1002/14651858.cd013438