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REMAP Trial for Optimizing Surgical Outcomes at UPMC (UPMC REMAP)

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ClinicalTrials.gov Identifier: NCT03861767
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
University of Pittsburgh Medical Center
Berry Consultants
Information provided by (Responsible Party):
Derek C. Angus, MD, MPH, University of Pittsburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Aging Drug: Metformin ER Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SPRY: Metformin LD-SC

LD-SC (low-dose, short course)

Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin LD-IC

LD-IC (low-dose, intermediate course)

Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin LD-LC

LD-LC (low-dose, long course)

Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin ID-SC

ID-SC (intermediate-dose, short course)

Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin ID-IC

ID-IC (intermediate-dose, intermediate course)

Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin ID-LC

ID-LC (intermediate-dose, long course)

Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin HD-SC

HD-SC (high-dose, short course)

After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin HD-IC

HD-IC (high-dose, intermediate course)

After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Experimental: SPRY: Metformin HD-LC

HD-LC (high-dose, long course)

After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.

Drug: Metformin ER
tablet
Other Name: Metformin Extended Release

Placebo Comparator: SPRY: Placebo
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Drug: Placebo
Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.




Primary Outcome Measures :
  1. Hospital free days (HFD) [ Time Frame: Day 90 from the date of the elective surgical procedure ]
    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.


Secondary Outcome Measures :
  1. Incidence of ICU admission after surgery [ Time Frame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed ]
  2. Incidence of Re-operation following index procedure [ Time Frame: 1 year following completion of study drug ]
  3. Number of participants with deep vein thrombosis (DVT) [ Time Frame: 1 year following completion of study drug ]
  4. Number of participants with pulmonary embolus (PE) [ Time Frame: 1 year following completion of study drug ]
  5. Number of participants with surgical site infection [ Time Frame: 1 year following completion of study drug ]
  6. Number of participants with surgical site occurrence [ Time Frame: 1 year following completion of study drug ]
  7. Organ failure free days [ Time Frame: Day 30 from the date of the elective surgical procedure ]
  8. Hospital length of stay (LOS) [ Time Frame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days ]
  9. ICU Length of stay (LOS) [ Time Frame: 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 ]
  10. Location to which participant is discharged [ Time Frame: Day 30 ]
  11. Hospital mortality rate [ Time Frame: Day 30 ]
  12. Survival rate [ Time Frame: Day 90 from the date of the elective surgical procedure ]
  13. Hospital readmission rate [ Time Frame: Day 365 from the date of the elective surgical procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861767


Contacts
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Contact: Derek C Angus, MD, MPH 412.647.6965 angusdc@ccm.upmc.edu
Contact: Matthew D Neal, MD 412.647.1158 nealm2@upmc.edu

Locations
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United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Matthew D Neal, MD    412-647-1158    nealm2@upmc.edu   
Principal Investigator: Derek C Angus, MD, MPH         
Principal Investigator: Matthew D Neal, MD         
Principal Investigator: Christopher W Seymour, MD, MSc         
Sponsors and Collaborators
Derek C. Angus, MD, MPH
University of Pittsburgh Medical Center
Berry Consultants
Investigators
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Principal Investigator: Derek C Angus, MD University of Pittsburgh

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Responsible Party: Derek C. Angus, MD, MPH, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03861767     History of Changes
Other Study ID Numbers: STUDY19090186
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Relevant data may be available 1 year following publication
Access Criteria: Data access is subject to a methodologically sound proposal and the necessary data sharing agreements.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Derek C. Angus, MD, MPH, University of Pittsburgh:
Prehabilitation
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs