Trial · NCT05900284
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Acute Kidney Injury at day 30 or discharge | Hospital discharge or day 30, whichever comes first. | AKI will be measured using the worse creatinine and urine output daily for 7 days and at discharge or day 30, whichever comes first. |
| Secondary | Number of patients requiring Renal Replacement Therapy within the hospitalization | Hospital discharge or 30 days, whichever comes first. | Participants will be assessed on the need for any form of intermittent or continuous renal replacement therapy. |
| Secondary | In-hospital Mortality | Hospital discharge or Day 30 | The proportion of patients who died while in the hospital |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT05900284/registered