Trial · NCT00843986
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation) | Baseline and 72 Hours | MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Primary | Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale | 24 Hours | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance | Baseline, 24 Hours, 48 Hours and 72 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance | Baseline, 24 Hours, 48 Hours and Day 9 | Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation. MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function | Day 9 | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Termination of Study Drug Due to an Adverse Event or Intolerability | 48.5 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point Likert scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity). Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge) | Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9 | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Total Loop Diuretic Use Through 48 Hours | 48 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Secondary | Total Urine Output at Hours 6, 12, 24, 48 and 72 | 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
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.
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