Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients (CITRA-SAFE)

Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients: A Retrospective Series

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Chronic Kidney Infection
• Intervention / Treatment: Other: CITRASATE SLED

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.

• Study Type: Observational
• Enrollment (Anticipated): 61

Contacts and Locations

• Study Contact: Name: Jonathan CHARBIT, MD; Phone Number: 33 467338256; Email: j-charbit@chu-montpellier.fr

Study Locations

• France
  • Montepllier
    • Montpellier, Montepllier, France, 34295
      • Recruiting
      • Uhmontpellier
      • Contact: Jonathan CHARBIT, MD; Phone Number: 33 467338256; Email: j-charbit@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CITRASAFE; Patient underwent CITRASATE dialysis session	Other: CITRASATE SLED; Applying of CITRASATE SLED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of blood ionized calcium level disorders	Retrospective assessment of 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.	baseline, per dialysis session
change of blood ionized calcium level disorders	Retrospective assessment of 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.	Day 1 (post dialysis session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of therapeutic consequences required	therapeutic consequences required in order to treat the ionized calcium troubles	day 1
Description of Clotting event	the efficacy of CITRASATE® with our restitution protocol during RRT absence	day 1
Description of Dialysis dose	the efficacy of CITRASATE® with our restitution protocol during RRT (optimal dialysis dose)	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Jonathan CHARBIT, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Renal Replacement Therapy; CITRASATE
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: RECHMPL21_0739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No