Trial · NCT07883447
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in blood interleukin-6 (IL-6) concentration from Day 1 to Day 4 | Day 1 (before intervention) and Day 4 after randomization | Blood IL-6 concentration will be measured on Day 1 before the intervention and on Day 4. Change will be calculated as the Day 4 value minus the Day 1 value. |
| Secondary | Area under the blood IL-6 concentration-time curve from Day 1 through Day 4 | Day 1 (before intervention), and day 2, 3 and 4 after randomization | The area under the curve will be calculated from blood IL-6 concentrations obtained from Day 1 before intervention through Day 4. |
| Secondary | Change in blood IL-6 concentration from Day 1 to Day 7 | Day 1 (before intervention) and Day 7 after randomization | Blood IL-6 concentration will be measured on Day 1 before the intervention and on Day 7. Change will be calculated as the Day 7 value minus the Day 1 value. |
| Secondary | Change in blood C-reactive protein (CRP) concentration from Day 1 to Days 4 and 7 | Day 1 (before intervention), Day 4, and Day 7 after randomization | Blood CRP concentration will be measured on Days 1, 4, and 7. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 value. |
| Secondary | Change in blood interleukin-10 (IL-10) concentration from Day 1 to Days 4 and 7 | Day 1 (before intervention), Day 4, and Day 7 after randomization | Blood IL-10 concentration will be measured on Days 1, 4, and 7. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 value. |
| Secondary | Change in blood procalcitonin concentration from Day 1 to Days 4 and 7 | Day 1 (before intervention), Day 4, and Day 7 after randomization | Blood procalcitonin concentration will be measured on Days 1, 4, and 7. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 value. |
| Secondary | Change in Sequential Organ Failure Assessment (SOFA) score from Day 1 to Days 4 and 7 | Day 1 (before intervention), Day 4, and Day 7 after randomization | The SOFA score assesses dysfunction across six organ systems. Total scores range from 0 to 24; higher scores indicate greater organ dysfunction. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 score. |
| Secondary | Blood concentrations of 58 lipid mediators | Day 1 (before intervention), Day 4, and Day 7 after randomization | Concentrations of the 58 prespecified lipid mediators. The lipid mediators are listed in Table 2 of Hartling et al. Clin Chem Lab Med. 2021;59(11):1811-1823. doi:10.1515/cclm-2021-0644 |
| Secondary | Red blood cell eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels | Day 1 (before intervention), Day 4, and Day 7 after randomization | EPA and DHA levels in red blood cells will be measured and reported separately. |
| Secondary | Rectus femoris cross-sectional area measured by ultrasound | Day 1 (before intervention); Day 7 or ICU discharge (whichever comes first); and Day 28 or hospital discharge (whichever comes first) after randomization | Ultrasound will be used to measure the cross-sectional area (cm2) of the rectus femoris muscle at each assessment |
| Secondary | Quadriceps muscle layer thickness measured by ultrasound | Day 1 (before intervention); Day 7 or ICU discharge (whichever comes first); and Day 28 or hospital discharge (whichever comes first) after randomization | Ultrasound will be used to measure quadriceps muscle layer thickness (cm) at each assessment. |
| Secondary | Number of participants who died in the ICU, in the hospital, by Day 28, and by Day 60 | During the ICU and hospital stays, each up to Day 60 after randomization; and by Days 28 and 60 after randomization | All-cause deaths will be counted separately during the ICU stay, during the hospital stay, by Day 28, and by Day 60 after randomization. |
| Secondary | Intensive care unit (ICU) length of stay | From ICU admission until ICU discharge or death, up to Day 60 after randomization | Number of days from ICU admission until ICU discharge or death, assessed up to Day 60 after randomization. |
| Secondary | Hospital length of stay | From hospital admission until hospital discharge or death, up to Day 60 after randomization | Number of days from hospital admission until hospital discharge or death, assessed up to Day 60 after randomization. |
| Secondary | Duration of Mechanical Ventilation | From ICU admission until hospital discharge, death, or Day 60 after randomization, whichever occurs first | Total number of days receiving invasive mechanical ventilation from ICU admission during the assessment period. Days from separate episodes will be summed. |
| Secondary | Day 28 persistent organ dysfunction or death | From randomization through Day 28 for death; on Day 28 after randomization for ongoing organ support | Participants will be counted if they die by Day 28 or, if alive on Day 28, still require at least one of the following: vasopressors or inotropes, mechanical circulatory support, dialysis, or mechanical ventilation. |
| Secondary | Handgrip strength measured with a handgrip dynamometer | At ICU discharge and hospital discharge, with each assessment occurring no later than Day 28 after randomization | Handgrip strength will be measured using a handgrip dynamometer and reported as the measured grip force in kilogram |
| Secondary | Knee extension strength measured with MicroFET2 Handheld dynamometer | At hospital discharge, or on Day 28 after randomization if the participant remains hospitalized | Knee extension strength will be measured using a MicroFET2 Handheld dynamometer and reported in kilogram |
| Secondary | Medical Research Council sum score for muscle strength | Before hospital discharge, up to Day 28 after randomization | Strength in six muscle groups on each side of the body is graded from 0 to 5 and summed. The total score ranges from 0 to 60; higher scores indicate greater muscle strength. |
| Secondary | Short Physical Performance Battery (SPPB) total score | Before hospital discharge, up to Day 28 after randomization | The SPPB assesses standing balance, usual gait speed, and repeated chair stands. Each component is scored from 0 to 4; the total score ranges from 0 to 12, with higher scores indicating better physical performance. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07883447/registered