Trial · NCT07898462
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days alive and free of organ support to day 28 | From randomisation through day 28 after randomisation. | Number of days during the first 28 days after randomisation on which the participant is alive and receives none of the protocol-defined forms of organ support. Organ support is defined as treatment with a vasopressor or inotropic infusion, the need for respiratory support or the need for new renal replacement therapy. |
| Secondary | All-cause mortality | 28 days, 90 days, 6 months and 12 months after randomisation | Percentage of participants who have died from any cause by each specified follow-up time point. Mortality will be assessed separately at 28 days, 90 days, 6 months and 12 months after randomisation. |
| Secondary | Days alive and free of organ support to day 90 | From randomisation through day 90 after randomisation. | Number of days during the first 90 days after randomisation on which the participant is alive and receives none of the protocol-defined forms of organ support. Organ support is defined as treatment with a vasopressor or inotropic infusion, the need for respiratory support or the need for new renal replacement therapy. |
| Secondary | Proportion of patients treated with new-onset renal replacement therapy | From randomisation through day 90 after randomisation. | Percentage of participants who commence renal replacement therapy after randomisation and on or before day 90. |
| Secondary | Days alive and free of invasive mechanical ventilation through day 90 | From randomisation through day 90 after randomisation | Number of days during the first 90 days after randomisation on which the participant is alive and does not receive invasive mechanical ventilation |
| Secondary | Days alive and outside the intensive care unit through day 90 | From randomisation through day 90 after randomisation | Number of days during the first 90 days after randomisation on which the participant is alive and is not admitted to an intensive care unit |
| Secondary | Days alive outside hospital through day 90 | From randomisation through day 90 after randomisation | Number of days during the first 90 days after randomisation on which the participant is alive and is not admitted to hospital. |
| Secondary | Number of hospital readmissions through day 90 | 90 days after randomisation | Number of hospital readmissions per participant following discharge from the index hospital admission and occurring on or before day 90 after randomisation. |
| Secondary | Number of new-onset infections during the index hospital admission | From 2 days after randomisation until discharge from the index hospital admission. | Number of new-onset infections per participant during the index hospital admission, defined by commencement of new antibiotic treatment at least 2 days after randomisation. Antibiotics commenced for perioperative prophylaxis are excluded. Includes new-onset bacteraemia. |
| Secondary | Functional status assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 90 days, 6 months and 12 months after randomisation. | Functional status will be assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Each item is scored from 0 (no difficulty) to 4 (extreme difficulty or inability to perform the activity), giving a total score ranging from 0 to 48. Higher scores indicate greater disability and worse functional status. |
| Secondary | Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score | 90 days, 6 months and 12 months after randomisation. | EuroQol (Quality of life) 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Health-related quality of life will be assessed using the country-appropriate EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. '5-D' Refers to the five dimensions of health it measures: Mobility, Usual activities, Self-care, Pain/discomfort, Anxiety/depression. '5-L' refers to the five response levels for each dimension, which are: no problems, slight, moderate, severe, extreme/unable to. Responses will be converted into an index score using the applicable country-specific value set. Higher scores indicate better health-related quality of life. |
| Secondary | Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS) index score | 90 days, 6 months and 12 months after randomisation. | Measuring the participant's self-rated overall health on a 0-100 scale, with 100 being the best and 0 the worst. |
| Other | Percentage of participants with hypokalaemia | From randomisation through day 8 after randomisation. | Percentage of participants with at least one measured blood potassium concentration \<3.5 mmol/L |
| Other | Percentage of participants with hyperkalaemia | From randomisation through day 8 after randomisation. | Percentage of participants with at least one measured blood potassium concentration \>5.0 mmol/L |
| Other | Percentage of participants with hyponatraemia | From randomisation through day 8 after randomisation. | Percentage of participants with at least one measured blood sodium concentration \<135 mmol/L. |
| Other | Percentage of participants with hypernatraemia | From randomisation through day 8 after randomisation. | Percentage of participants with at least one measured blood sodium concentration \>150 mmol/L during the assessment period. |
| Other | Average daily net fluid balance in millilitres | Daily measurements from baseline through day 8 after randomisation. | Daily net fluid balance is calculated as total recorded fluid input minus total recorded fluid output during each daily recording interval, expressed in millilitres |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07898462/registered