Trial · NCT04251351
Effect of Paracetamol on Kidney Function in Severe Malaria
NCT04251351, Phase 3, Unknown, University of British Columbia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Paracetamol on Kidney Function in Severe Malaria. Trials, record NCT04251351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04251351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Paracetamol on Kidney Function in Severe Malaria
- NCT number
- NCT04251351
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 460 participants, estimated
- Lead sponsor
- University of British Columbia
- Conditions
- Severe Malaria, Malaria,Falciparum, Acute Kidney Injury, Paracetamol
- Interventions
- Paracetamol, Mechanical antipyresis
- First posted
- 2020-01-31
- Last updated
- 2023-06-13
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute kidney injury (AKI) or death among patients enrolled without AKI (Composite outcome) | during first 7 days of enrolment | Composite outcome of development of AKI (defined as creatinine ≥26.5 µmol/L or ≥1.5x baseline), or death at any timepoint |
| Primary | Acute kidney injury (AKI) progression or death among patients enrolled with AKI (Composite outcome) | during first 7 days of enrolment | Composite outcome of worsening of AKI (defined as creatinine ≥2x baseline, or ≥3x baseline, or initiation of RRT or eGFR \<35 ml/min/ 1.73 m2) or death at any timepoint. |
| Secondary | Number of patients with serious adverse events | AST/ALT/total bilirubin during the first 5 days from enrolment; mortality assessed Day 0 to 7. | Number of patients with serious adverse events (mortality and/or hepatotoxicity, as defined by Hy's Law). |
| Secondary | Proportion of patients who develop Major Adverse Kidney Events (MAKE) composite | 90 days | Major Adverse Kidney Events (MAKE) composite, defined as ≥ 1 efficacy renal endpoints: (i) death, (ii) need for renal replacement therapy, (iii)≥ 50% reduction in eGFR from baseline to 90 days. |
| Secondary | Fever clearance time | 6-hourly temperature assessments during first 7 days from enrolment | Time taken for aural temperature: (i) to fall \< 37.5°C (FCT-A), and (ii) to fall \< 37.5°C and remain there for \>24 h (FCT-B) |
| Secondary | Coma recovery | 6-hourly GCS/BCS assessments during first 7 days from enrolment | Time until Glasgow Coma Score (GCS) return to 15 (or Blantyre Coma Score (BCS) return to 5 in preverbal children) |
| Secondary | Longitudinal change in renal function | During the first 7 days from enrolment | As measured by creatinine concentration (umol/L) |
| Secondary | Longitudinal change in markers of hemolysis | during the first 3 days from enrolment | As measured by cell-free haemoglobin (ug/mL), haemopexin (ug/mL), haptoglobin (ug/mL), haem (uM), F2-isoprostane (pg/mL) and isofurans (pg/mL) concentrations |
| Secondary | Longitudinal change of endothelial activation | during the first 3 days from enrolment | As measured by concentrations of angiopoietin-Tie2 pathway markers (i.e. Ang-1, Ang-2, sTie2, sTie1) |
| Secondary | Longitudinal change of immune activation | during the first 3 days from enrolment | As measured by soluble triggering receptor expressed on myeloid cells concentration (sTREM-1; pg/mL) |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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/NCT04251351
GET https://conductscience.org/api/trials/v1/NCT04251351/registered?page=2