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Trial · NCT05697770

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMAKE30 score30 days or at hospital discharge (whichever occurs first)
The primary outcome is MAKE30 from the date of randomisation. MAKE30 is defined as a composite of death from any cause, receipt of RRT, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline), all censored at hospital discharge or 30 days, whichever occurs first.
Secondary30-day in-hospital mortality30 days or at hospital discharge (whichever occurs first)All-cause in-hospital mortality at day 30
SecondaryReceipt of renal replacement therapy in the first 30 days30 days or at hospital discharge (whichever occurs first)Receipt of renal replacement therapy in the first 30 days
SecondaryPersistent renal dysfunction30 days or at hospital discharge (whichever occurs first)Defined as an elevation of the creatinine level to ≥ 200% of baseline
SecondaryRenal replacement therapy dependence at day 3030 days or at hospital discharge (whichever occurs first)Defined by the receipt of any form of renal replacement therapy within ± 10 days of the 30-day time point following randomisation
SecondaryICU mortality30 days or at hospital discharge (whichever occurs first)All-cause ICU mortality at day 30
SecondaryHospital mortality90 days or at hospital discharge (whichever occurs first)All-cause hospital mortality at day 90
Secondary90-day in-hospital mortality90 days or at hospital discharge (whichever occurs first)All-cause mortality at day 90
OtherRecurrence of metabolic acidosis in the first 7 days after randomization7 days after randomizationDefined as pH \< 7.30, BE ≤ -4 mEq/L and PaCO2 ≤ 45 mmHg
OtherIncidence and the maximum stage of AKI in the first 7 days after randomization7 days after randomizationAccording to KDIGO criteria
OtherVasopressor-free days at day 3030 days or at hospital discharge (whichever occurs first)Defined as 30 - days receiving a continuous infusion of vasopressor \[at any time and for any duration\]; non-survivors at day 30 will receive 0
OtherRenal replacement therapy-free days at day 3030 days or at hospital discharge (whichever occurs first)Defined as 30 - days receiving RRT; non-survivors at day 30 will receive 0
OtherICU-free days at day 3030 days or at hospital discharge (whichever occurs first)Defined as 30 - ICU length of stay; non-survivors at day 30 will receive 0
OtherHospital-free days at day 9090 days or at hospital discharge (whichever occurs first)Defined as 90 -hospital length of stay; non-survivors at day 90 will receive 0
OtherHealth-Related Quality of Life180 daysEQ-5D-5L

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.

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