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Remote Ischemic Conditioning in Abdominal Surgery

NCT03234543 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-02-25

No results posted yet for this study

Summary

This phase II randomized (1:1) controlled trial will examine the effects of remote ischemic conditioning (RIC) on the outcomes of major abdominal surgery. One hundred subjects will be enrolled at a single institution - University Hospital - Newark. The study population are patients undergoing major abdominal surgery (anticipated to be \>/= 2 hrs long with a hospital stay \>/= 2 days). Subjects in the treatment group will receive lower limb ischemic conditioning at 3 different time points: before surgery, POD 1 and POD 2. The primary outcome is the 30-day comprehensive complications index (CCI). Key secondary outcomes are changes in systemic inflammatory markers in peripheral blood and 30-day mortality.

Conditions

  • Laparotomy
  • Laparoscopy
  • Retroperitoneal Disease
  • Pelvis Disease
  • Pancreatic Diseases
  • Liver Diseases
  • Gastrointestinal Disease
  • Urologic Diseases
  • Complication of Surgical Procedure

Interventions

PROCEDURE

Remote ischemic conditioning

Placement of blood pressure cuff to lower extremity in order to induce temporary and reversible ischemia.

PROCEDURE

No Remote ischemic conditioning

Placement of blood pressure cuff to lower extremity with minimal inflation without inducing ischemia.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Baburao Koneru, MD, MPH · Rutgers-NJMS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-08
Primary Completion
2019-06-15
Completion
2020-06-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234543 on ClinicalTrials.gov