Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis

NCT04297839 | Suspended Phase 3 DMC FDA Drug

• 1 other identifier: 6293
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Data on regional citrate anticoagulation in patients with acute kidney injury (AKI) treated by hybrid or extended dialysis are scarce and heterogeneous. The path batch system (Genius®) or the proportion hemodialysis machines are well suited equipments to perform extended dialysis. However, clotting of the system might occur with relatively high frequency, especially in critically ill patients with high risk of clotting or in those with contraindication to the use of heparin. The aims of this study are: 1) to test and to validate a new protocol using citrate to perform regional anticoagulation in AKI patients admitted to the intensive care unit (ICU) and treated by extended dialysis, using a control group (use of heparin or intermittent saline flush) as comparison in the Heart Institute of the university medical complex "Clinics Hospital Medical School at São Paulo" (Hospital das Clínicas da Faculdade de Medicina do Estado de São Paulo) and at the Cancer Institute of the São Paulo State; 2) to evaluate the anticoagulation in these procedures with citrate and compare with the control group using heparin or saline flush, so the primary end point would be the rates of system clotting; 3) to study the calcium mass transfer in these procedures and its impact on bone metabolism in these patients. The inclusion criteria are all AKI patients admitted in these places and candidates to renal replacement therapy using the extended dialysis, age above 18 years. The exclusion criteria are acute liver failure, hemorrhagic stroke, platelets level below 20,000/mm3, and active bleeding needing transfusional support (two or more red cell packs in 24 hours).

Conditions

Hemodialysis Complication; Acute Kidney Injury; Anticoagulant Toxicity

Keywords

Extended Hemodialysis; Anticoagulation; Citrate; Heparin; Coagulation in Dialysis

Outcome Measures

Primary Outcomes (1)

• Clotting rate

  Clotting of the dialysis system with complete impossibility to continue the therapy

  through all dialysis session, an average of 8 hours

Secondary Outcomes (19)

• Parathyroid hormone (PTH), Fibroblast growth factor-23 (FGF-23), Procollagen type 1 N-terminal propeptide (P1NP), Esclerostin and Telopeptide carboxiterminal of type I collagen (cTX)

  through all dialysis session, an average of 8 hours

• Dialysate calcium

  through all dialysis session, an average of 8 hours

• Serum ionized and total calcium levels

  through all dialysis session, an average of 8 hours

• Serum sodium concentration

  through all dialysis session, an average of 8 hours

• Serum potassium concentration

  through all dialysis session, an average of 8 hours

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in this group will receive heparin during hemodialysis sessions, at a dose of 1.000 units at the beginning and 500 units per hour in a syringe infusion pump. If the patient has a contraindication for the heparin use, it will receive saline continuous administration. This is the actual standard of care performed in extended hemodialysis sessions.

Drug: Control Group (heparin or continuous saline)

Citrate Group

EXPERIMENTAL

Patients in this group will receive regional citrate anticoagulation, with acid-citrate-dextrose 2.2% (ACD). Dose of 3 mmol per liter of filtered blood. The systemic calcium levels are measured every two hours and a solution of calcium chloride is infused in a peripheral venous access, accordingly to citrate infusion rate and the systemic calcium values.

Drug: Citrate Anticoagulation Solution

Interventions

Citrate Anticoagulation Solution DRUG

Regional citrate anticoagulation in extended hemodialysis sessions compared to the standard of care actually performed in these therapies (heparin or continuous saline infusion)

Also known as: Citrate

Citrate Group

Control Group (heparin or continuous saline) DRUG

Use of heparin in hemodialysis sessions. If there is any contraindication against the use of heparina, the investigators will perform saline flush of the dialysis system

Also known as: Heparin, Saline

Control Group

Eligibility Criteria

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

You may qualify if:

• All patients with acute kidney injury admitted to the intensive care unit and candidates for extended dialysis (renal replacement therapy)
• Age over 18 years.

You may not qualify if:

• Acute liver failure
• Hemorrhagic stroke in the last 30 days
• Patients with platelet levels below 20,000/mm3
• Active bleeding requiring transfusion (two or more red blood cell packs within 24 hours)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• InCor Heart Institute: collaborator
• Hospital do Cancer, Sao Paulo: collaborator

Study Sites (1)

University of São Paulo Medical School

São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Citric Acid; Control Groups; Heparin; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label randomized clinical trial with cross-over between the groups

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: March 6, 2020
• Study Start: February 12, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

BR (1)