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REMAP Trial for Optimizing Surgical Outcomes at UPMC

NCT03861767 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2024-06-18

Study results available
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Summary

The purpose of this project is to determine the effect of various interventions to improve patient outcome as defined by hospital free days at day 90 for adult patients undergoing elective surgery. Within this project, multiple studies may be conducted.

The structure of this project permits:

* the testing of multiple treatments at the same time within the same patient
* the use of early study results to provide better treatment options to future patients
* the removal of treatments which are shown to be less effective than the other treatments
* the addition of new treatments

The first study to be conducted under this project (IRB STUDY19090186) is the Strategies to Promote ResiliencY (SPRY) clinical trial (IRB PRO18060038).

The SPRY clinical trial will determine the effectiveness of Metformin on improving surgical outcomes among nondiabetic older adults who are scheduled for elective surgery.

Conditions

  • Aging

Interventions

DRUG

Placebo

Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.

DRUG

Metformin ER

tablet

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Berry Consultants

    collaborator OTHER

  • Matthew Neal MD

    lead OTHER

Principal Investigators

  • Matthew D Neal, MD, FACS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2022-09-23
Completion
2022-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03861767 on ClinicalTrials.gov