Trial · NCT01973335
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acetazolamide Arm: Natriuresis 24 h | 24h | For the acetazolamide arm of the study, the primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 h after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). Subsequently, patients receiving acetazolamide and low-dose loop diuretics (both the groups with and without upfront spironolactone together) are compared to patients not receiving acetazolamide but high-dose loop diuretics instead (both the groups with or without upfront spironolactone together) |
| Primary | Spironolactone Arm: Incidence of Hypo- (Serum Potassium <3.5 mmol/L) or Hyperkalemia (Serum Potassium >5.0 mmol/L) | 72h | For the spironolactone arm of the study, the primary end-point is the incidence of either hypo- (serum potassium \<3.5 mmol/L) or hyperkalemia (serum potassium \>5.0 mmol/L) at any of 3 morning blood samples at consecutive days after randomization. Patients receiving upfront spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy) are compared with them receiving no spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy). |
| Secondary | NT-proBNP Change After 72 h | 72h | Relative NT-proBNP change (%) after 72 h compared to baseline. |
| Secondary | Number of Participants With Worsening Renal Function | 72h | Worsening renal function is defined as a rise in serum creatine \>0.3 mg/dL or a \>20% decrease in estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula compared to baseline at any time point before 72 h. Serum creatinine values are assessed at three consecutive mornings after study inclusion. |
| Secondary | Persistent Renal Impairment | 4 weeks after hospital discharge | Persistent renal impairment is defined as a persistently elevated serum creatine \>0.3mg/dL or \>20% decrease in estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, above the baseline value of the patient and will be assessed on a scheduled follow-up appointment 4 weeks after hospital discharge. |
| Secondary | Peak Plasma Aldosterone Concentration After 72 h | 72h | At three consecutive mornings after study inclusion, blood samples will be taken to assess plasma aldosterone levels. The highest value will constitute the peak plasma aldosterone concentration (ng/L). |
| Secondary | Peak Plasma Renin Activity After 72 h | 72h | At three consecutive mornings after study inclusion, blood samples will be taken to assess plasma renin activity. The highest value will constitute the peak plasma renin activity (ng/mL/h). |
| Other | Natriuresis 48 h | 48h | Total natriuresis (mmol) after 48 h. |
| Other | Natriuresis 72 h | 72h | Total natriuresis (mmol) after 72 h. |
| Other | Diuresis 24 h | 24h | Total amount of urine output (L) after 24 h. |
| Other | Diuresis 48 h | 48h | Total amount of urine output (L) after 48 h. |
| Other | Diuresis 72 h | 72h | Total amount of urine output (L) after 72 h. |
| Other | Weight Change After 72 h | 72h | Body weight change after 72 h compared to admission. |
| Other | Visual Analogue Scale Score for Dyspnea After 24 h | 24h | Scale name and construct: Visual analogue scale presented as a line with a movable indicator. Far left of the line indicates no dyspnea at all and far right of the line indicates the worst imaginable dyspnea. The participant can move the indicator to one certain point among the line and the investigator can read at the back a number going from 0 to 100 with 0 indicating no dyspnea and 100 the worst imaginable dyspnea. |
| Other | Visual Analogue Scale Score for Dyspnea After 48 h | 48h | |
| Other | Visual Analogue Scale Score for Dyspnea After 72 h | 72h | |
| Other | 4-point Likert Scale for Edema After 24 h | 24h | |
| Other | 4-point Likert Scale for Edema After 48 h | 48h | |
| Other | 4-point Likert Scale for Edema After 72 h | 72h | |
| Other | Incidence of Therapy-refractory Congestion | 72h | Need for combinational diuretic therapy with thiazide-type diuretics, bail-out ultrafiltration or renal replacement therapy |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01973335/registered