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NCT Number: NCT04446858

Non-invasive Evaluation of the Predictive Value of CEUS and SWE in 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.

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Key information

Conditions

Kidney Failure, Acute Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with portal hypertension and kidney failure

Exclusion criteria

  • no consent, no kidney failure, no portal hypertension

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: up to 10 years

    death, liver transplantation

Secondary outcomes

  1. Ascites

    Time frame: up to 10 years

    Evaluation of amount of ascites according to the Child-Score

  2. Hepatic Encephalopathy

    Time frame: up to 10 years

    Evaluation of the grade according to the West Haven Criteria

  3. Variceal Bleeding

    Time frame: up to 10 years

    Assessment of presence of variceal bleeding

  4. Liver Failure

    Time frame: up to 10 years

    defined as Bilirubin level ≥ 12mg/dl

  5. Acute-on-Chronic Liver Failure

    Time frame: up to 10 years

    Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria

  6. Kidney Failure

    Time frame: up to 10 years

    Assessment of AKI according to KDIGO

  7. Organ Failures

    Time frame: up to 10 years

    Assessment of Organ failures according to CLIF-Sequential Organ Failure Assessment (SOFA) Score

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Chang, MD

CONTACT

[email protected]

+49(0)228-287 15770

Michael Praktiknjo, MD

CONTACT

[email protected]

+49(0)228-287 15770

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study 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

Acronym: NECTAR

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jun 25, 2020
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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