PREdiction of succeSSful weanING From Continuous Renal Replacement Theraphy: the Possible Role of Delta C-cistatin

NCT06714214 | Recruiting

• 1 other identifier: PRESSING
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to know if, in patients with acute kidney injury, naive for renal injurie, admitted to different ICUs, the change in plasma concentration of c-cistatin, between initiation and discontinuation of CRRT, is a predictive finding to optimize the withdrawal time of renal support

Conditions

Acute Kidney Injury

Keywords

C cistatin; acute kidney injury; CRRT; weaning

Outcome Measures

Primary Outcomes (1)

• the change in plasma concentration of c-cistatin between initiation and discontinuation of CRRT is a predictive finding in patients with acute kidney injury admitted to the ICU

  To verify whether the change in plasma concentration of c-cistatin between initiation and discontinuation of CRRT is a predictive finding in patients with acute kidney injury admitted to the ICU It is measured as (cistatin at weaning minus cistatin basal) divided by cistatine basal, in percentage

  From enrlollment to the weaning from CRRT and 14 days after

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all adult patients suffering from acute renal injury needing to CRRT, admitted to the enrolling centers starting from the approval of the Ethics Committee

You may qualify if:

• age ≥ 18 years;
• diagnosis of acute kidney injury (defined according to KDIGO 2012 criteria)
• need for support with CRRT according to the indications of the nephrologist consultants and Clinical Practice
• Obtaining informed consent

You may not qualify if:

• CRRT already ongoing (in another department not participating in the study) at the time of transfer/admission to intensive care;
• need for RRT (any type and modality) in the 14 days prior to enrolment;
• diagnosis of AKD/CKD/ESRF on admission;
• Discontinuation of CRRT under conditions that do not comply with the criteria established by the study;
• Need for CRRT not associated with AKI condition (e.g. elimination of toxicants);
• pregnant women;
• presence of known thyreopathy
• Continuous use of corticosteroids
• patient with known neoplastic disease.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Anestesia e Terapia Intensiva nelle emergenze locali, regionali e nazionale e nella chirurgia addominale maggiore

Bologna, 40138, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna -Anestesiologia e terapia intensiva polivalente

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood to dose c-cistatin

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Francesco Marino, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Marino, MD

CONTACT

3293842166; francesco.marino@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 3, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-09

Locations

IT (2)