Evidence map›Paper›PMID 38688665›Full record

ArticleBMJ open2024

Metformin for sepsis-associated AKI: a protocol for the Randomized Clinical Trial of the Safety and FeasibiLity of Metformin as a Treatment for sepsis-associated AKI (LiMiT AKI).

Ivan E Saraiva, Natsumi Hamahata, David T Huang, Sandra L Kane-Gill, Ryan M Rivosecchi, Sruti Shiva, Thomas D Nolin, Xinlei Chen, John Minturn, Chung-Chou H Chang and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05900284 (A Randomized Clinical Trial of the Safety and Feasibility of Metformin as a Treatment for Sepsis Induced AKI.), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05900284 phase2completednot on this map

A Randomized Clinical Trial of the Safety and Feasibility of Metformin as a Treatment for Sepsis Induced AKI.

TypeinterventionalSponsorHernando GomezRan2023 to 2026Enrolled80ConditionsSepsis, Septic Shock, Acute Kidney Injury, MetforminArmsMetformin low dose, Metformin high dose, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Review
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  14. Targeting AMP-activated protein kinase in sepsis.Frontiers in endocrinology · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Ivan E SaraivaCRISMA Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Natsumi HamahataDepartment of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
David T HuangCRISMA Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Sandra L Kane-GillCRISMA Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Ryan M RivosecchiDepartment of Pharmacy, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.
Sruti ShivaDepartment of Pharmacology & Chemical Biology, Vascular Medical Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Thomas D NolinDepartment of Pharmacy & Therapeutics, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Xinlei ChenDepartment of Biostatistics, School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
John MinturnCRISMA Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Chung-Chou H ChangDepartment of Biostatistics, School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Xiaotong LiDepartment of Pharmacy & Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, Pennsylvania, USA.
John KellumProgram for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Hernando GómezCRISMA Center, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA gomezh@upmc.edu.ORCID 0000-0001-5605-3513

Funding

Multidisciplinary Training in Critical Care Outcomes ResearchT32HL007820 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Timothy D Girard, Jeremy M Kahn · 1996 to 2026
$6.4M
A Randomized Clinical Trial of the Safety and FeasibiLity of Metformin as a Treatment for sepsis induced AKI (LiMiT AKI)R01DK133142 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI GOMEZ DANIES, HERNANDO · 2023 to 2025
$941k
NHLBI NIH HHS T32 HL007820NIDDK NIH HHS R01 DK133142
6 · The paper itself

Abstract

introductionAcute kidney injury (AKI) is a common complication of sepsis associated with increased risk of death. Preclinical data and observational human studies suggest that activation of AMP-activated protein kinase, an ubiquitous master regulator of energy that can limit mitochondrial injury, with metformin may protect against sepsis-associated AKI (SA-AKI) and mortality. The Randomized Clinical Trial of the Safety and FeasibiLity of Metformin as a Treatment for sepsis-associated AKI (LiMiT AKI) aims to evaluate the safety and feasibility of enteral metformin in patients with sepsis at risk of developing SA-AKI. METHODS AND ANALYSIS: Blind, randomised, placebo-controlled clinical trial in a single-centre, quaternary teaching hospital in the USA. We will enrol adult patients (18 years of age or older) within 48 hours of meeting Sepsis-3 criteria, admitted to intensive care unit, with oral or enteral access. Patients will be randomised 1:1:1 to low-dose metformin (500 mg two times per day), high-dose metformin (1000 mg two times per day) or placebo for 5 days. Primary safety outcome will be the proportion of metformin-associated serious adverse events. Feasibility assessment will be based on acceptability by patients and clinicians, and by enrolment rate. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board. All patients or surrogates will provide written consent prior to enrolment and any study intervention. Metformin is a widely available, inexpensive medication with a long track record for safety, which if effective would be accessible and easy to deploy. We describe the study methods using the Standard Protocol Items for Randomized Trials framework and discuss key design features and methodological decisions. LiMiT AKI will investigate the feasibility and safety of metformin in critically ill patients with sepsis at risk of SA-AKI, in preparation for a future large-scale efficacy study. Main results will be published as soon as available after final analysis. TRIAL REGISTRATION NUMBER: NCT05900284.

Indexed as

Acute Kidney InjuryFeasibility StudiesHypoglycemic AgentsMetforminSepsisAdolescentAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicYoung AdultHypoglycemic AgentsMetforminAcute renal failureAdult intensive & critical careClinical TrialFeasibility Studies

Identifiers

PMID38688665
PMCPMC11086423

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.