Comparison · NCT05411991-sae
Intervention Arm vs Control Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Intervention Arm vs Control Arm: serious adverse events. Trial comparisons, record NCT05411991-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05411991-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.115 | 0.054 | 0.23 | wilson | |
| Risk in group 2 | 0.275 | 0.171 | 0.409 | wilson | |
| Risk difference, group 1 minus group 2 | -0.159 | -0.307 | -0.00499 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.42 | 0.175 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.345 | 0.121 | 0.985 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intervention Arm than on Control Arm | 6.28 | 3.25 | 200 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention Arm | Application of a standardized diuretic schedule with following key components:~* Serial post-diuretic spot urine sodium (UNa) assessment~* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)~* Upfront use of intravenous acetazolamide 500 mg OD~* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia~* Full nephron blockade for diuretic resistance~* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics | 6 | 52 | EG000 |
| Group 2 | Control Arm | Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.~Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. | 14 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 days
Source ClinicalTrials.gov
Trial
- Title
- Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
- NCT number
- NCT05411991
- Phases
- PHASE4
- Conditions
- Acute Heart Failure, Diuretics Drug Reactions
- Interventions
UNa measurement after intravenous loop diuretic bolus, Intravenous acetazolamide 500 mg OD, Intravenous bumetanide TID, Oral chlorthalidone OD, Intravenous canrenoate 200 mg OD, Maintenance infusion, Oral potassium supplements, Intravenous hypertonic saline, Switch to oral diuretic therapy, Usual AHF care
- Lead sponsor
- Vrije Universiteit Brussel
- Results first posted
- 2025-08-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05411991?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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