Trial · NCT05900284
Safety and Feasibility of Metformin for Sepsis Induced AKI
NCT05900284, Phase 2, Completed, Hernando Gomez
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Feasibility of Metformin for Sepsis Induced AKI. Trials, record NCT05900284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05900284
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Feasibility of Metformin for Sepsis Induced AKI
- NCT number
- NCT05900284
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Hernando Gomez
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury, Metformin
- Interventions
- Metformin low dose, Metformin high dose, Placebo
- First posted
- 2023-06-12
- Last updated
- 2026-06-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The development of metformin associated serious adverse events (mSAE) which will include hyperlactatemia, hypoglycemia, metabolic acidosis and/or gastrointestinal intolerance during the treatment period | Hospital discharge or 30 days, whatever occurs first | Safety will be measured by monitoring the patient for the development of metformin associated serious adverse events (mSAE) which will include hyperlactatemia, hypoglycemia, metabolic acidosis and/or gastrointestinal intolerance during the treatment period. In addition, patients will be monitored for any adverse event or any significant adverse event. |
| Primary | Feasibility: Recruitment, retention and adherence | Hospital discharge or 30 days, whatever occurs first | Investigators will quantify the number of patients screened and consented, the number of patients completing the study treatment, and the number of protocol deviations. |
| Primary | Feasibility: Investigating the reasons for denial of enrollment by patients, surrogates or clinicians | Hospital discharge or 30 days, whatever occurs first | Investigators will identify barriers to implementing the intervention perceived by physicians, patients, or patients' surrogates who decline to participate or who drop out by requesting their feedback. |
| Primary | Feasibility: Data accrual and loss to follow-up | Hospital discharge or 30 days, whatever occurs first | Investigators will estimate the proportion of randomized patients that achieve complete acquisition of outcome and ancillary data and lost to follow-up, and the proportion of missing data per variable. |
| Secondary | Area under the curve of the concentration of the renal biomarker TIMP2 (Time Point 2)/ Insulin-like growth factor-binding protein (IGFBP7) in time | Baseline, Day 1, 3, 5 to define the area under the concentration curve | Investigators will measure the area under the curve of concentration of the tubular biomarker TIMP2/IGFBP7 vs. time using levels at baseline, day 1, 3 and 5. |
| Secondary | Pharmacokinetic Accumulation Profile | Day 5 | Metformin accumulation levels will be assessed from study blood samples day 5 blood obtained at 0.5h, 1h, 2h, 4h, 8h, 12h, after administration of the last dose of Metformin. |
| Secondary | Pharmacokinetic Absorption Profile | Day 2 | Metformin absorption kinetics will be assessed from study blood samples on Day 2, blood will be obtained at 0.5h, 1h, 2h, 4h, 8h, 12h, after first dose administration of Metformin. |
| Secondary | Change in Platelet Mitochondrial Respiration | Change from baseline, Day 1, 3, 5 | Platelet bioenergetic profile will be assessed by measuring the oxygen consumption rate in the presence of sequential blockade of the different components of the electron transport chain using the SeaHorse analyzer on a subset of participants from each treatment arm. |
| Secondary | Change in Platelet Mitochondrial Electron Transport Chain Complex Expression | Change from baseline, Day 1, 3, 5 | Platelet mitochondrial transport chain complex expression will be quantified by western blot using a LI-COR machine normalized to the Integrin alfa-2b protein. |
| Secondary | Acute Kidney Injury at day 7 | At day 7 | AKI will be measured using the worse creatinine and urine output daily for 7 days and at discharge or day 30, whichever comes first. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38688665 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK133142 | A Randomized Clinical Trial of the Safety and FeasibiLity of Metformin as a Treatment for sepsis induced AKI (LiMiT AKI) | GOMEZ DANIES, HERNANDO | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2023 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05900284
GET https://conductscience.org/api/trials/v1/NCT05900284/registered