AgingPhase 3UPMCREMAPNCT03861767

REMAP Trial for Optimizing Surgical Outcomes at UPMC

A Phase 3 study testing Metformin ER in people with Aging, run by Matthew Neal MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aging
What is being tested?: Metformin ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2019to 23 Sep 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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

Who cannot join

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
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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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.

Conditions: Aging
Being tested: Metformin ER, Placebo
Keywords: Prehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metformin ERDrug
Also called Metformin Extended Release
tablet
PlaceboDrug
Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.

Study groups in NCT03861767
Study group	Role	What they receive
SPRY: Metformin LD-SC (low-dose, short course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin LD-IC (low-dose, intermediate course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin LD-LC (low-dose, long course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin ID-SC (intermediate-dose, short course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin ID-IC (intermediate-dose, intermediate course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin ID-LC (intermediate-dose, long course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin HD-SC (high-dose, short course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin HD-IC (high-dose, intermediate course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Metformin HD-LC (high-dose, long course)	Experimental	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. Receives: Drug: Metformin ER
SPRY: Placebo	Placebo comparator	Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 90 from the date of the elective surgical procedure

Secondary outcomes (14)

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.
Measured: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days in the event ICU admission is needed
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
Measured: Day 90 from the date of the elective surgical procedure
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
Measured: Day 90 from the date of the elective surgical procedure
Number of Participants With Surgical Site Infection
Measured: Day 30 from the date of the elective surgical procedure
Number of Participants With Surgical Site Occurrence
Measured: Day 30 from the date of the elective surgical procedure
Organ Failure Free Days
Measured: Day 30 from the date of the elective surgical procedure
Hospital Length of Stay (LOS)
Measured: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days
ICU (Intensive Care Unit) Length of Stay (LOS)
Measured: 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
Mortality
Measured: Day 90 from the date of the elective surgical procedure
Hospital Readmission Rate
Measured: Day 90 from the date of the elective surgical procedure
Gastrointestinal Intolerance
Measured: From enrollment to day 90 after surgery
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
Measured: From enrollment to day 90 after surgery
Discharge Disposition
Measured: 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
In Hospital Mortality
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201923 Sep 2022

First posted4 Mar 2019
Study start15 Apr 2019
Primary completion23 Sep 2022
Study completion23 Sep 2022

Why it stopped: Not enough enrollment due to the COVID19 pandemic.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AgingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03861767
Sponsor's protocol ID: STUDY19090186
Acronym: UPMCREMAP
Status last verified: May 2024
First submitted: 21 Jan 2019
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 32994242

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aging trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Optimizing Surgical Outcomes at UPMC
ClinicalTrials.gov ID: NCT03861767
Acronym / sponsor ID: UPMCREMAP / STUDY19090186
Conditions: Aging
Keywords: Prehabilitation
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Not enough enrollment due to the COVID19 pandemic.
Enrolment: 302 participants (actual)
Lead sponsor: Matthew Neal MDUniversity, hospital or other
Collaborators: University of Pittsburgh Medical Center, Berry Consultants
Study start: 15 Apr 2019 (actual)
Primary completion: 23 Sep 2022 (actual)
Study completion: 23 Sep 2022 (actual)
First posted: 4 Mar 2019 (actual)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 10

Arm	Type	Receives
SPRY: Metformin LD-SC (low-dose, short course)	Experimental	Drug: Metformin ERLD-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.
SPRY: Metformin LD-IC (low-dose, intermediate course)	Experimental	Drug: Metformin ERLD-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.
SPRY: Metformin LD-LC (low-dose, long course)	Experimental	Drug: Metformin ERLD-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.
SPRY: Metformin ID-SC (intermediate-dose, short course)	Experimental	Drug: Metformin ERID-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.
SPRY: Metformin ID-IC (intermediate-dose, intermediate course)	Experimental	Drug: Metformin ERID-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.
SPRY: Metformin ID-LC (intermediate-dose, long course)	Experimental	Drug: Metformin ERID-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.
SPRY: Metformin HD-SC (high-dose, short course)	Experimental	Drug: Metformin ERHD-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.
SPRY: Metformin HD-IC (high-dose, intermediate course)	Experimental	Drug: Metformin ERHD-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.
SPRY: Metformin HD-LC (high-dose, long course)	Experimental	Drug: Metformin ERHD-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.
SPRY: Placebo	Placebo comparator	Drug: PlaceboParticipants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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
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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Metformin ERAlso: Metformin Extended Releasetablet	Drug	SPRY: Metformin HD-IC (high-dose, intermediate course), SPRY: Metformin HD-LC (high-dose, long course), SPRY: Metformin HD-SC (high-dose, short course), SPRY: Metformin ID-IC (intermediate-dose, intermediate course), SPRY: Metformin ID-LC (intermediate-dose, long course), SPRY: Metformin ID-SC (intermediate-dose, short course), SPRY: Metformin LD-IC (low-dose, intermediate course), SPRY: Metformin LD-LC (low-dose, long course), SPRY: Metformin LD-SC (low-dose, short course)
PlaceboMatched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.	Drug	SPRY: Placebo

Primary outcome

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.

14 secondary outcomes

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
Incidence and Total Number of Reoperation/Reintervention
Time frame: Day 90 from the date of the elective surgical procedure
Venous Thromboembolic Events Including Deep Vein Thrombosis and Pulmonary Embolism
Time frame: Day 90 from the date of the elective surgical procedure
Number of Participants With Surgical Site Infection
Time frame: Day 30 from the date of the elective surgical procedure
Number of Participants With Surgical Site Occurrence
Time frame: Day 30 from the date of the elective surgical procedure
Organ Failure Free Days
Time frame: Day 30 from the date of the elective surgical procedure
Hospital Length of Stay (LOS)
Time frame: Participants will be followed for the duration of their hospital admission, estimated to be 2-4 days
ICU (Intensive Care Unit) 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
Mortality
Time frame: Day 90 from the date of the elective surgical procedure
Hospital Readmission Rate
Time frame: Day 90 from the date of the elective surgical procedure
Gastrointestinal Intolerance
Time frame: From enrollment to day 90 after surgery
SAE (Serious Adverse Event) as Defined in Core Protocol (Mild, Moderate, Severe, Life Threatening/Disabling; Adjudicated as Related, Possibly Related, Unrelated)
Time frame: From enrollment to day 90 after surgery
Discharge Disposition
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
In Hospital Mortality
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.

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPRY: Metformin LD-SC (Low-dose, Short Course)	39	37
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)	20	19
SPRY: Metformin LD-LC (Low-dose, Long Course)	5	5
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)	39	34
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)	19	17
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)	8	7
SPRY: Metformin HD-SC (High-dose, Short Course)	40	37
SPRY: Metformin HD-IC (High-dose, Intermediate Course)	26	25
SPRY: Metformin HD-LC (High-dose, Long Course)	0	0
SPRY: Placebo	106	101

Primary outcome: Hospital Free Days (HFD)

Time frame: Day 90 from the date of the elective surgical procedure. Median (Inter-Quartile Range). Unit: Days

Measure	SPRY: Metformin LD-SC (Low-dose, Short Course) n = 36	SPRY: Metformin LD-IC (Low-dose, Intermediate Course) n = 20	SPRY: Metformin LD-LC (Low-dose, Long Course) n = 5	SPRY: Metformin ID-SC (Intermediate-dose, Short Course) n = 35	SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) n = 19	SPRY: Metformin ID-LC (Intermediate-dose, Long Course) n = 8	SPRY: Metformin HD-SC (High-dose, Short Course) n = 38	SPRY: Metformin HD-IC (High-dose, Intermediate Course) n = 23	SPRY: Metformin HD-LC (High-dose, Long Course) n = 0	SPRY: Placebo n = 98
Value	87 (84.8 to 89.2)	88.5 (86.8 to 90)	85 (84 to 85)	88 (85 to 90)	88 (86.5 to 90)	89.5 (89 to 90)	88 (85 to 90)	87 (84 to 90)	–	87 (85 to 90)

SPRY: Metformin LD-SC (Low-dose, Short Course) vs SPRY: Metformin LD-IC (Low-dose, Intermediate Course) vs SPRY: Metformin LD-LC (Low-dose, Long Course) vs SPRY: Placebo: Odds Ratio (OR): 1.14 (95% CI 0.67 to 1.97)
SPRY: Metformin ID-SC (Intermediate-dose, Short Course) vs SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course) vs SPRY: Metformin ID-LC (Intermediate-dose, Long Course) vs SPRY: Placebo: Odds Ratio (OR): 0.72 (95% CI 0.42 to 1.25)
SPRY: Metformin HD-SC (High-dose, Short Course) vs SPRY: Metformin HD-IC (High-dose, Intermediate Course) vs SPRY: Placebo: Odds Ratio (OR): 1.06 (95% CI 0.61 to 1.84)

Population analysed: Participants were analyzed using intention-to-treat analysis. Participants that did not undergo an operation were excluded.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time the participant is prescribed the study drug until 90 days after surgery.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPRY: Metformin LD-SC (Low-dose, Short Course)	11 of 39 (28.2%)	10 of 39 (25.6%)	0 of 39
SPRY: Metformin LD-IC (Low-dose, Intermediate Course)	5 of 20 (25%)	5 of 20 (25%)	0 of 20
SPRY: Metformin LD-LC (Low-dose, Long Course)	2 of 5 (40%)	2 of 5 (40%)	0 of 5
SPRY: Metformin ID-SC (Intermediate-dose, Short Course)	10 of 39 (25.6%)	9 of 39 (23.1%)	1 of 39
SPRY: Metformin ID-IC (Intermediate-dose, Intermediate Course)	6 of 19 (31.6%)	5 of 19 (26.3%)	0 of 19
SPRY: Metformin ID-LC (Intermediate-dose, Long Course)	2 of 8 (25%)	2 of 8 (25%)	0 of 8
SPRY: Metformin HD-SC (High-dose, Short Course)	12 of 40 (30%)	11 of 40 (27.5%)	0 of 40
SPRY: Metformin HD-IC (High-dose, Intermediate Course)	4 of 26 (15.4%)	3 of 26 (11.5%)	0 of 26
SPRY: Metformin HD-LC (High-dose, Long Course)	0 of 0	0 of 0	0
SPRY: Placebo	12 of 106 (11.3%)	10 of 106 (9.4%)	0 of 106

Limitations and caveats (from the sponsor): Recruitment was terminated early and was limited by the COVID-19 pandemic, as such the study is underpowered and could not meet its set goals. No patients fell in the high dose long course group since no participants were randomized to that group

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32994242Reitz 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew D Neal, MD, FACS principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin ER in people with Aging, run by Matthew Neal MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Free Days (HFD) (time frame: Day 90 from the date of the elective surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.