REMAP Trial for Optimizing Surgical Outcomes at UPMC

Aging Clinical Trial

— UPMCREMAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03861767
• Other study ID #: STUDY19090186
• Status: Terminated
• Phase: Phase 3
• Start date: April 15, 2019
• Est. completion date: September 23, 2022

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 302
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

UPMC REMAP

Inclusion Criteria:

• Adult patient evaluated pre-operatively for elective surgery at UPMC

• Minimum lead time before surgery to provide domain specific intervention (range 7-180 days pre-operatively)

• Age greater to or equal to 18 years of age

Exclusion Criteria:

• Death is deemed to be imminent or inevitable

• Emergency surgical procedure without suitable lead-in time

• Previous participation in this REMAP within the last 90 days, flagged by elective or emergency surgical encounter at UPMC in the past 90 days

SPRY Domain

Inclusion Criteria:

• Age >= 60 years

• Age < 60 but evidence of comorbidity risk as represented by a Charlson Comorbidity Index of > 2 in 12 months prior to enrollment

• Able to take an oral medication in non-crushable pill form

• Women must be post-menopausal, which is defined as not having a menstrual period within the last 12 months

Exclusion Criteria:

• The treating clinician believes that participation in the domain would not be in the best interest of the patient

• Pre-existing diabetes type I or II

• Women of child-bearing potential

• Hospital stay <24 hours

• Presently taking metformin or prior use in the past 6 months

• Evidence of an absolute or relative contraindication to Metformin therapy

• Known allergy to metformin

• Acute or chronic metabolic acidosis with or without coma

• Hemodialysis, end-stage renal disease, or Glomerular Filtration Rate (GFR) < 45 in the prior 30 days

• Ongoing treatment with therapy known to have significant drug-drug interaction with metformin (carbonic anhydrase inhibitors, cimetidine, gliptins)

• History of lactic acidosis

• History of excessive alcohol intake

• Severe hepatic dysfunction

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Metformin ER
tablet
• Placebo
Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Matthew Neal MD	Berry Consultants, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Free Days (HFD)	90 - the number of days during the index stay minus the number of days readmitted during the 90 days after surgery. Death within 90 days after surgery is recorded as -1 HFD.	Day 90 from the date of the elective surgical procedure
Secondary	Incidence of ICU Admission After Surgery	The intended measure of this outcome is to get the rate of ICU admission per described group or the number of participants that had an ICU admission within each group.	Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed
Secondary	Incidence and Total Number of Reoperation/Reintervention	This outcome is also intended to measure the rate of Reoperation/reintervention within each group or the total number of participants that had a Reoperation/reintervention within each group as shown below	Day 90 from the date of the elective surgical procedure
Secondary	Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism	The intended measure from this outcome is to also show the rate of Venous thromboembolic events or the number of participants with Venous thromboembolic events within each group	Day 90 from the date of the elective surgical procedure
Secondary	Number of Participants With Surgical Site Infection		Day 30 from the date of the elective surgical procedure
Secondary	Number of Participants With Surgical Site Occurrence		Day 30 from the date of the elective surgical procedure
Secondary	Organ Failure Free Days		Day 30 from the date of the elective surgical procedure
Secondary	Hospital Length of Stay (LOS)		Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days
Secondary	ICU (Intensive Care Unit) Length of Stay (LOS)		Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed
Secondary	Mortality		Day 90 from the date of the elective surgical procedure
Secondary	Hospital Readmission Rate		Day 90 from the date of the elective surgical procedure
Secondary	Gastrointestinal Intolerance		From enrollment to day 90 after surgery
Secondary	SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)	The number of participants here includes the full cohort because adverse events were recorded for all participants while other outcome measures were only recorded for participants that underwent surgery	From enrollment to day 90 after surgery
Secondary	Discharge Disposition		Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed
Secondary	In Hospital Mortality		Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days, in the event admission to an ICU is needed.