Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients

NCT ID: NCT05313230

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-06-30

Brief Summary

Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.

The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.

Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.

The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients.

Detailed Description

This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records.

A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records.

The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.

The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit.

Conditions

Acute Kidney Injury; Chronic Kidney Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

CITRASAFE

Patient underwent CITRASATE dialysis session

CITRASATE SLED

Intervention Type: OTHER

Applying of CITRASATE SLED

Interventions

CITRASATE SLED

Applying of CITRASATE SLED

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021

Exclusion Criteria

• Patient underwent RRT without CITRASATE® protocol
• Lack of data
• Ethical limitation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan CHARBIT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, Montepllier, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jonathan CHARBIT, MD

Role: CONTACT

j-charbit@chu-montpellier.fr

467338256 ext. 33

Facility Contacts

Jonathan CHARBIT, MD

Role: primary

j-charbit@chu-montpellier.fr

467338256 ext. 33

Other Identifiers

RECHMPL21_0739

Identifier Type: -

Identifier Source: org_study_id