Continuous Renal Replacement Therapy (CRRT) in Surgery Room During Orthotopic Liver Transplantation (OLT)

NCT06844435 | Completed

• 1 other identifier: CRRT-OLT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study is interventional, non-pharmacological, single-center. The aim of this study is to test the possible added value of CRRT in the surgery room during liver transplantation, compared to the investigators center current practice in which CRRT is suspended and possibly restarted at the end of the operation. The incidence of some clinical and metabolic alterations that often complicate transplantation in the absence of CRRT will be evaluated, by measuring a series of parameters related to the state of water filling, acid-base balance, general metabolic structure, hemodynamics and supportive drugs. Some parameters related to patient safety will be evaluated. The results of this exploratory study will be useful to document what was rationally hypothesized, that is, that the continuation of dialysis treatment even during the hours of surgery, in this narrow category of patients, is actually useful to reduce the possible clinical and metabolic complications, intra- and/or post-operative (within 48 hours of transplant), linked to the simultaneous presence of renal failure. The statistical analysis is aimed at analyzing the behavior of different indicators of clinical complications and comparing them with what was found in the historical series, in the hypothesis that with the new procedure the analyzed parameters are better. In detail, the mean values at the end of treatment will be compared for:

• Central venous pressure
• Potassiemia
• Lactatemia
• pH The following will also be evaluated:
• dose of vasoconstrictor drugs, defined by the variation between the dose at the beginning of administration during the anhepatic phase and the maximum dose reached
• pulmonary congestion/pulmonary edema, defined by radiological signs of alveolar congestion/edema on chest X-ray in the post-surgery period
• safety parameters: episodes of hypokalemia requiring supplementation (K\<3.5 mmol/l), post-surgery hypophosphatemia, number of coagulation events in the extracorporeal circuit, appearance of cardiac arrhythmias.

Conditions

Liver Failure; Acute Kidney Injury; Kidney Disease, Chronic

Keywords

CRRT; Liver transplant

Outcome Measures

Primary Outcomes (4)

• central venous pressure average values at the end of treatment

  Central venous pressure (cmH2O)

  during surgery

• Potassiemia average values at the end of tretment

  Potassiemia (mmol/L)

  during surgery

• Lactatemia average values at the end of treatment

  Lactatemia (mmol/L)

  during surgery

• pH average values at the end of treatment

  pH (absolute value)

  during surgery

Secondary Outcomes (6)

• dose of vasocostrictors drugs

  during surgery

• pulmunary congestion

  during surgery

• safety parameters: episodes of hypokalemia

  during surgery

• safety parameters: post-surgery hypophosphatemia

  during surgery

• safety parameters: number of coagulation events in the extracorporeal circuit

  during surgery

Other Outcomes (5)

• Survival at 3 and 6 months post intervention

  3 and 6 months post intervention

• INR at 3 and 6 months post intervention

  3 and 6 months post intervention

• Bilirubin at 3 and 6 months post intervention

  3 and 6 months post intervention

Study Arms (1)

CRRT during OLT

OTHER

CRRT during OLT

Other: continuous renal replacement therapy

Interventions

continuous renal replacement therapy OTHER

continuous renal replacement therapy during OLT in surgery room

CRRT during OLT

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for ISOLATED LIVER TRANSPLANT with acute or chronic renal failure already undergoing continuous dialysis treatment in Intensive Care at the time of arrival of the organ. If acute renal failure: stage 2-3 of the KDIGO classification (referring to diuresis).
• Patients scheduled for COMBINED LIVER-KIDNEY TRANSPLANT, whether or not they are already undergoing continuous dialysis treatment in Intensive Care at the time of arrival of the organ to be implanted
• Patients scheduled for ISOLATED LIVER TRANSPLANT, for acute liver failure and with acute renal failure in stage 3 of the KDIGO classification (referring to diuresis) for which there is an indication for continuous dialysis.
• Age ≥ 18 years
• Signature of informed consent

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Liver Failure; Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Davide Ricci, Md, Phd

  IRCCS Azienda ospedaliero-Universitaria di Bologna Policlinico di S'Orsola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is aimed at analyzing the behavior of different indicators of clinical complications and comparing them with what was found in the historical series, in the hypothesis that with the new procedure the analyzed parameters are better.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: February 25, 2025
• Study Start: February 22, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: February 25, 2025

Record last verified: 2024-12

Locations

IT (1)