Health TrialsbyHealthPanel

HRS-AKI Treatment With TIPS in Patients With Cirrhosis

ConditionsCirrhosis, LiverHepatorenal SyndromeAcute Kidney InjuryAscites Hepatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJena University Hospital

About this trial

The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage1, 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests

Clinically evident ascites due to portal hypertension

HRS-AKI

Age: ≥ 18 to ≤ 80 years old at the time of consent

Disqualifiers

Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or high-dosed iodinated contrast medium) in the previous 72 hours before AKI diagnosis

Improvement of renal function after 1 day of diuretic removal and plasma volume expansion with albumin 1-1.5 gr/kg

Uncontrolled shock within the last 48 hours prior to randomization

Patients with uncontrolled infection (defined by a 20 % increase in inflam-matory parameters (CRP, leucocytes or insufficient decrease of PMN in ascitic fluid < 25 % from baseline in the case of a SBP) despite 48 hours of antibiotic treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TIPS

    Procedure/Surgery

    A transjugular intrahepatic portosystemic shunt (TIPS) is implanted into the cirrhotic liver

  • Standard of Care

    Drug

    Terlipressin/Albumin treatment is the preferred standard of care treatment. In the case Terlipressin is not tolerated treatment with Noradrenaline may be considered following actual guidelines.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: TIPS groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

12 month Liver transplant-free survival

12 month Liver transplant-free survival

Time frame
12 months after Baseline

Secondary outcomes

1

3-month liver transplant free survival

3-month liver transplant free survival

Time frame
3 months after Baseline
2

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

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

Time frame
within 12 months after Baseline
3

Development of further decompensation of HRS-AKI during follow-up

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

Time frame
within 12 months after Baseline
4

Reversal of HRS-AKI-AKI 3 MFU

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).

Time frame
3 months after Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jena University Hospital

Lead sponsor

German Research Foundation

Collaborator

University Hospital Halle (Saale)

Collaborator

Source ClinicalTrials.gov
Apply now