Kidney Failure, AcuteNECTARNCT04446858
Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome
An observational study of Kidney Failure, Acute, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Failure, Acute
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 1 Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with portal hypertension and kidney failure are eligible for inclusion
Who may be able to join
- All patients with portal hypertension and kidney failure
Who cannot join
- no consent, no kidney failure, no portal hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn
Michael Praktiknjo, MD, +49228 28715770, michael.praktiknjo@ukbonn.de
Johannes Chang, MD, +49228 28715770, johannes.chang@ukbonn.de
About this study
Official title: Non-invasive Evaluation of the Predictive Value of CEUS and SWE in Patients With and Without TIPS With ACLF, Renal Failure and Hepatorenal Syndrome
Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Read the detailed description
NECTAR consists of patients with ACLF and renal failure with and without receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
- Conditions
- Kidney Failure, Acute
- Keywords
- transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, circulating biomarkers, Transthoracic echocardiography (TTE) with Speckle-tracking, Elastography, Contrast-enhanced ultrasound, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), Urine biomarker
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With TIPS | Prospective cohort that received TIPS | |
| Without TIPS | Prospective cohort that did not receive TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
death, liver transplantation
Measured: up to 10 years
Secondary outcomes (7)
Ascites
Evaluation of amount of ascites according to the Child-Score
Measured: up to 10 years
Hepatic Encephalopathy
Evaluation of the grade according to the West Haven Criteria
Measured: up to 10 years
Variceal Bleeding
Assessment of presence of variceal bleeding
Measured: up to 10 years
Liver Failure
defined as Bilirubin level ≥ 12mg/dl
Measured: up to 10 years
Acute-on-Chronic Liver Failure
Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria
Measured: up to 10 years
Kidney Failure
Assessment of AKI according to KDIGO
Measured: up to 10 years
Organ Failures
Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Jan 2021
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Praktiknjo, University Hospital, Bonn
- Investigators
- Michael Praktiknjo, MD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446858
- Sponsor's protocol ID
- NECTAR
- Acronym
- NECTAR
- Status last verified
- May 2022
- First submitted
- 22 Jun 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No