Trial · NCT05346393
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 12 month Liver transplant-free survival | 12 months after Baseline | 12 month Liver transplant-free survival |
| Secondary | 3-month liver transplant free survival | 3 months after Baseline | 3-month liver transplant free survival |
| Secondary | Number of patient which develop an indication for TIPS placement (variceal bleeding or refractory ascites) or TIPS revision (variceal bleeding or development of ascites) during follow-up | within 12 months after Baseline | Number of patient which develop an indication for TIPS placement according to clinical guidelines (such as variceal bleeding or refractory ascites) in the control group or indication for a TIPS revision (variceal bleeding, development of ascites) in the intervention group will be assessed during the 12 months follow-up |
| Secondary | Development of further decompensation of HRS-AKI during follow-up | within 12 months after Baseline | Development of further decompensation as defined in the Baveno VII Consensus Workshop (e.g. overt hepatic encephalopathy, refractory or recurrent ascites, dilutional hyponatremia, new AKI-HRS, variceal bleeding) during follow-up |
| Secondary | Reversal of HRS-AKI-AKI 3 MFU | 3 months after Baseline | Reversal of HRS-AKI-AKI at 3 months (vs. baseline), defined as return of serum creatinine level within 0.3 mg/dl (26 mmol/L). |
| Secondary | Reversal of HRS-AKI-AKI 12 MFU | 12 months after Baseline | Reversal of HRS-AKI-AKI at 12 months (vs. baseline), defined as return of serum creatinine level within 0.3 mg/dl (26 mmol/L). |
| Secondary | Partial response to treatment 3 MFU | 3 months after Baseline | Partial response to treatment at 3 months (vs. baseline) defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 mmol/L) above the baseline value. |
| Secondary | Partial response to treatment 12 MFU | 12 months after Baseline | Partial response to treatment at 12 months (vs. baseline) defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 mmol/L) above the baseline value. |
| Secondary | In-hospital survival | baseline until 12 months | In-hospital survival of the patients (patients are hospitalized for diagnosis of HRS-AKI and start of treatment - due to poor diagnosis, patients may die during hospital stay) |
| Secondary | 28-day survival | baseline until day 28 after baseline | 28-day survival |
| Secondary | 90-day survival | baseline until day 90 after baseline | 90-day survival |
| Secondary | Length of in-hospital-stay | baseline until 12 months | Length of in-hospital-stay of the patients (patients are hospitalized for diagnosis of HRS-AKI and start of treatment) |
| Secondary | Changes in HrQoL as measured by SF36 3 MFU | 3 months after Baseline | Relative changes in Health-related Quality of Life as measured by SF36 at 3 months (vs. baseline) |
| Secondary | Changes in HrQoL as measured by SF36 12 MFU | 12 months after Baseline | Relative changes in Health-related Quality of Life as measured by SF36 at 12 months (vs. baseline) |
| Secondary | Changes in HrQoL as measured by CLDQ 3 MFU | 3 months after Baseline | Relative changes in Health-related Quality of Life as measured by CLDQ (Chronic Liver Disease Questionnaire) at 3 months (vs. baseline) |
| Secondary | Changes in HrQoL as measured by CLDQ 12 MFU | 12 months after Baseline | Relative changes in Health-related Quality of Life as measured by CLDQ (Chronic Liver Disease Questionnaire) at 12 months (vs. baseline) |
| Secondary | Need for renal replacement therapy | 12 months after Baseline | Need for renal replacement therapy within Follow-up |
| Secondary | recurrence of HRS-AKI after treatment at 3 months | 3 months after Baseline | recurrence of HRS-AKI after treatment at 3 months |
| Secondary | recurrence of HRS-AKI after treatment at 12 months | 12 months after Baseline | recurrence of HRS-AKI after treatment at 12 months |
| Secondary | Safety Assessment | 12 months after Baseline | Number of AEs and SAEs in each group with special attention on the development of acute on chronic liver failure and signs of heart failure. |
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.
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GET https://conductscience.org/api/trials/v1/NCT05346393/registered