Clinical trial NCT03861767: REMAP Trial for Optimizing Surgical Outcomes at UPMC
Official title: Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Aging
Keywords: Prehabilitation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
name: Berry Consultants
First posted: 2019-03-04
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Hospital Free Days (HFD)
timeFrame: Day 90 from the date of the elective surgical procedure
Secondary outcomes:
measure: Incidence of ICU Admission After Surgery
timeFrame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed
measure: Incidence and Total Number of Reoperation/Reintervention
timeFrame: Day 90 from the date of the elective surgical procedure
measure: Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism
timeFrame: Day 90 from the date of the elective surgical procedure
measure: Number of Participants With Surgical Site Infection
timeFrame: Day 30 from the date of the elective surgical procedure
measure: Number of Participants With Surgical Site Occurrence
timeFrame: Day 30 from the date of the elective surgical procedure
measure: Organ Failure Free Days
timeFrame: Day 30 from the date of the elective surgical procedure
measure: Hospital Length of Stay (LOS)
timeFrame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days
measure: ICU (Intensive Care Unit) Length of Stay (LOS)
timeFrame: 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
measure: Mortality
timeFrame: Day 90 from the date of the elective surgical procedure
measure: Hospital Readmission Rate
timeFrame: Day 90 from the date of the elective surgical procedure
measure: Gastrointestinal Intolerance
timeFrame: From enrollment to day 90 after surgery
measure: SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
timeFrame: From enrollment to day 90 after surgery
measure: Discharge Disposition
timeFrame: 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
measure: In Hospital Mortality
timeFrame: 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.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Matthew D Neal, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reitz KM, Seymour CW, Vates J, Quintana M, Viele K, Detry M, Morowitz M, Morris A, Methe B, Kennedy J, Zuckerbraun B, Girard TD, Marroquin OC, Esper S, Holder-Murray J, Newman AB, Berry S, Angus DC, Neal M. Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients. BMJ Open. 2020 Sep 29;10(9):e037690. doi: 10.1136/bmjopen-2020-037690.