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

NCT05313230 | Unknown

• 1 other identifier: RECHMPL21_0739
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Chronic Kidney Infection

Keywords

Renal Replacement Therapy; CITRASATE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Description of therapeutic consequences required

  day 1

• Description of Clotting event

  day 1

• Description of Dialysis dose

  day 1

Study Arms (1)

CITRASAFE

Patient underwent CITRASATE dialysis session

Other: CITRASATE SLED

Interventions

CITRASATE SLED OTHER

Applying of CITRASATE SLED

CITRASAFE

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

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, Montepllier, 34295, France

RECRUITING

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

• Jonathan CHARBIT, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan CHARBIT, MD

CONTACT

467338256; j-charbit@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: April 6, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

FR (1)