REMAP Trial for Optimizing Surgical Outcomes at UPMC
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | March 2019 |
| End Date: | July 31, 2020 |
| Contact: | Derek C Angus, MD, MPH |
| Email: | angusdc@ccm.upmc.edu |
| Phone: | 412.647.6965 |
Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC
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 PRO18060039) 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.
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 PRO18060039) 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.
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
- Blood glucose lower limit (<54 mg/dL)
- 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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Derek C Angus, MD, MPH
Phone: 412-647-1158
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