drugset / Trial / NCT03861767

REMAP Trial for Optimizing Surgical Outcomes at UPMC

NCT03861767 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2019-04-15
Primary completion
2022-09-23
Completion
2022-09-23

Outcome

Missed primary endpoint

Stopped (Enrollment): “Not enough enrollment due to the COVID19 pandemic.”

registry Odds Ratio (OR) 1.14 (95% CI 0.67 to 1.97) NCT03861767 ↗

registry Odds Ratio (OR) 0.72 (95% CI 0.42 to 1.25) NCT03861767 ↗

registry Odds Ratio (OR) 1.06 (95% CI 0.61 to 1.84) NCT03861767 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg —
Subject Metformin Small molecule 1000 mg —
Subject Metformin Small molecule 1500 mg —

Indications

No indication recorded.