Comparison · NCT05575219-sae
Intervention (Protocolized Clonidine Initiation) vs Usual Care (Without Protocolized Clonidine Initiation): 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 (Protocolized Clonidine Initiation) vs Usual Care (Without Protocolized Clonidine Initiation): serious adverse events. Trial comparisons, record NCT05575219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05575219-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 | 0 | 0.107 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000347 | 0.0385 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0385 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention (Protocolized Clonidine Initiation) | A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.~Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.~* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.~* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.~* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.~* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours). | 0 | 32 | EG001 |
| Group 2 | Usual Care (Without Protocolized Clonidine Initiation) | Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.~Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion. | 0 | 96 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal
- NCT number
- NCT05575219
- Phases
- PHASE4
- Conditions
- Withdrawal; Therapeutic Substance
- Interventions
- Clonidine (without protocolized initiation), Clonidine (protocolized initiation)
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Results first posted
- 2025-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05575219?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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