Trial · NCT04540094
Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital
NCT04540094, Phase 3, Completed, University of Edinburgh; results first posted 2024-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital. Trials, record NCT04540094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04540094
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital
- NCT number
- NCT04540094
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- University of Edinburgh
- Conditions
- Sepsis
- Interventions
- Human albumin, Balanced crystalloid solution
- First posted
- 2020-09-07
- Last updated
- 2024-10-04
- Results first posted
- 2024-10-04
- Limitations and caveats
Full Health Economic Analysis was not possible to determine the difference in secondary care costs. It was determined that any comparative analysis of costs would be dominated by mortality difference between arms, with the inevitable lower costs and quality-adjusted life years (QALYs) associated with the higher mortality group, so full analysis of this data was not completed as it would not produce meaningful outcomes. All analyses outlined in the Statistical Analysis Plan were completed.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recruitment Rate | Approx 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | 30-day Mortality | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Data Completeness of Primary Outcome | 180 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Withdrawal From Study | Approx 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | 6 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Start of In-hospital Intravenous Fluids | From time of Randomisation until fluid first being administered measured up to 6 hours. | minutes | MEDIAN | |
| SECONDARY | In-hospital Mortality | From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 90-day Mortality | 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs | 6 hours | ml | MEDIAN | |
| SECONDARY | Length of Hospital Stay | 90 days | days | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recruitment Rate | 5% Human Albumin Solution | 150 | Participants | ||
| Recruitment Rate | Intravenous Balanced Crystalloid | 150 | Participants | ||
| 30-day Mortality | 5% Human Albumin Solution | 31 | Participants | ||
| 30-day Mortality | Intravenous Balanced Crystalloid | 22 | Participants | ||
| Data Completeness of Primary Outcome | 5% Human Albumin Solution | 147 | Participants | ||
| Data Completeness of Primary Outcome | Intravenous Balanced Crystalloid | 149 | Participants | ||
| Withdrawal From Study | 5% Human Albumin Solution | 3 | Participants | ||
| Withdrawal From Study | Intravenous Balanced Crystalloid | 1 | Participants | ||
| Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | 5% Human Albumin Solution | 33 | Participants | ||
| Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | Intravenous Balanced Crystalloid | 1 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5% Human Albumin Solution | 150 | |
| Overall Study | STARTED | Intravenous Balanced Crystalloid | 150 | |
| Overall Study | COMPLETED | 5% Human Albumin Solution | 150 | |
| Overall Study | COMPLETED | Intravenous Balanced Crystalloid | 150 | |
| Overall Study | NOT COMPLETED | 5% Human Albumin Solution | 0 | |
| Overall Study | NOT COMPLETED | Intravenous Balanced Crystalloid | 0 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and Lymphatic | Blood and lymphatic system disorders | 5% Human Albumin Solution | 3 | 150 | 3 |
| other | Blood and Lymphatic | Blood and lymphatic system disorders | Intravenous Balanced Crystalloid | 1 | 150 | 1 |
| other | Cardiac Disorders | Cardiac disorders | 5% Human Albumin Solution | 2 | 150 | 2 |
| other | Cardiac Disorders | Cardiac disorders | Intravenous Balanced Crystalloid | 1 | 150 | 1 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | 5% Human Albumin Solution | 3 | 150 | 3 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Intravenous Balanced Crystalloid | 0 | 150 | 0 |
| other | General disorders and administration | General disorders | 5% Human Albumin Solution | 2 | 150 | 2 |
| other | General disorders and administration | General disorders | Intravenous Balanced Crystalloid | 2 | 150 | 2 |
| other | Infections and infestations | Infections and infestations | 5% Human Albumin Solution | 0 | 150 | 0 |
| other | Infections and infestations | Infections and infestations | Intravenous Balanced Crystalloid | 2 | 150 | 2 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5% Human Albumin Solution | 43 | 150 |
| Total, all-cause mortality | Intravenous Balanced Crystalloid | 32 | 150 |
| Total, other adverse events | 5% Human Albumin Solution | 25 | 150 |
| Total, other adverse events | Intravenous Balanced Crystalloid | 20 | 150 |
| Total, serious adverse events | 5% Human Albumin Solution | 5 | 150 |
| Total, serious adverse events | Intravenous Balanced Crystalloid | 2 | 150 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38912884 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons17
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Developing Pulmonary Oedema | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Participants Needing Invasive Ventilation | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: 30-day Mortality | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Developing Allergy or Anaphylaxis | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Recruitment Rate | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Developing Acute Kidney Injury (AKI) | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Participants Needing Renal Replacement | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Patients Readmitted in First 90 Days After Discharge | Trial comparisons |
| 5% Human Albumin Solution vs Intravenous Balanced Crystalloid: Number of Participants Needing Intravenous Vasopressors | Trial comparisons |
1 to 10 of 17
See all 17 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04540094
GET https://conductscience.org/api/trials/v1/NCT04540094/registered?page=2