NCT03861767

REMAP Trial for Optimizing Surgical Outcomes at UPMC

Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Matthew Neal MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Metformin ER	tablet
DRUG	Placebo	Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.

Timeline

• Start date: 2019-04-15
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2019-03-04
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study