Trial · NCT04540094
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment Rate | Approx 1 year | We measured the recruitment rate to assess deliverability. We aimed to recruit 300 participants in approximately 1 year in a 1:1 ratio into each treatment arm. |
| Primary | 30-day Mortality | 30 days | Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups. |
| Secondary | Data Completeness of Primary Outcome | 180 days | Feasibility Outcome assessing the number of participants who provided data for clinical primary outcome (30 day mortality) |
| Secondary | Withdrawal From Study | Approx 1 year | Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection |
| Secondary | Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | 6 hours | Feasibility Outcome- number of patients who receive any other fluid apart from intervention or control in first 6 hrs after recruitment |
| Secondary | Time to Start of In-hospital Intravenous Fluids | From time of Randomisation until fluid first being administered measured up to 6 hours. | Feasibility Outcome- Time to start of in-hospital intravenous fluids |
| Secondary | In-hospital Mortality | From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days | Secondary Clinical Outcome |
| Secondary | 90-day Mortality | 90 days | Secondary Clinical Outcome |
| Secondary | Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs | 6 hours | Secondary Clinical Outcome- Volume of randomised fluid delivered in each arm in the first 6hrs |
| Secondary | Length of Hospital Stay | 90 days | Secondary Clinical Outcome |
| Secondary | Proportion of Patients Admitted to Critical Care (HDU/ICU) | 90 days | Secondary Clinical Outcome- Proportion of patients admitted to critical care (HDU/ICU) |
| Secondary | Length of Stay in Critical Care (HDU/ICU) | 90 days | Secondary Clinical Outcome- Length of stay in critical care (HDU/ICU) |
| Secondary | Number of Participants Needing Intravenous Vasopressors | From time of Randomisation until time of hospital discharge, measured up to 90 days. | Secondary Clinical Outcome-number of participants needing intravenous vasopressors |
| Secondary | Number of Participants Needing Renal Replacement | From time of Randomisation until time of hospital discharge, measured up to 90 days. | Secondary Clinical Outcome- Number of participants needing renal replacement |
| Secondary | Number of Participants Needing Invasive Ventilation | From time of Randomisation until time of hospital discharge, measured up to 90 days. | Secondary Clinical Outcome- Number of participants needing invasive ventilation |
| Secondary | Number of Patients Readmitted in First 90 Days After Discharge | 90 days | Secondary Clinical Outcome- Number of patients readmitted in first 90 days after discharge |
| Secondary | Number of Patients Developing Acute Kidney Injury (AKI) | 7 days | AKI Defined using National Institute for Health and Care Excellence (NICE) criteria: A diagnosis of AKI may be made if there is one of the following: A rise in serum creatinine of 26 micromol/L or greater within 48 hours. A 50% or greater rise in serum creatinine known or presumed to have occurred within the past 7 days. A fall in urine output to less than 0.5 mL/kg/hour for more than 6 hours. |
| Secondary | Number of Patients Developing Pulmonary Oedema | 7 days | Safety Radiology diagnosis or requirement for rescue management (new diuretic use) |
| Secondary | Number of Patients Developing Allergy or Anaphylaxis | 7 days | Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid) |
| Secondary | Health Related Quality of Life (EQ-5D-5L Questionnaire) | baseline | Health Economic Outcomes are measured using the the 5-level EQ-5D version (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A high score indicates a worse outcome. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead. |
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/NCT04540094/registered