CoV-Hep Study: Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19

NCT04487990 | Completed DMC

• 2 other identifiers: U1111-1252-019433351120.0.0000.0068
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Since the emergence of the new strain of betacoronavirus (SARS-CoV-2) and its important clinical repercussions, it has been described that patients with its associated pneumonia (COVID-19) have high rates of thrombotic events, including reduction in the dialyzers patency when undergoing renal replacement therapy. Several strategies for preventing the early loss of dialysers are described, and regional anticoagulation based on citrate is the preferred modality for preventing this complication. On the other hand, in patients with SARS-CoV-2 there are already descriptions of endothelial inflammation and activation of the coagulation cascade, including studies demonstrating the benefit of heparinization of these patients. Thus, this study aims to compare two different anticoagulation strategies in patients infected with COVID-19 with continued venovenous hemodialysis (CVVHD). From the indication of CVVHD, patients will be screened according to eligibility criteria and, if they fit these parameters, they will be randomized into two groups: Group A - Standard regional anticoagulation based on Citrate associated with infusion of low doses of unfractionated heparin 10ui/kg/hour and Group B - Standard regional anticoagulation based on Citrate only. Patients will be randomized in blocks and followed for 72 hours. The primary endpoint is dialyzer patency at the end of 72 hours of clinical follow-up. Secondary objectives will be mortality, bleeding rate, drop in hematimetric indices, urea sieving, filter time in hours, down time of therapy, system and dialyser pressures (PBE and PTM). All patients will undergo a standard procedure with a prescribed dose of 30mL/Kg/H, blood flow of 150mL/minute and polysulfone dialyzer.

Conditions

Acute Kidney Injury; Covid19

Keywords

acute kidney injury; continuous venovenous hemodialysis; anticoagulation; heparin; citrate; covid-19

Outcome Measures

Primary Outcomes (1)

• Clotted dialyzers

  The percentage of clotted dialyzers within 72 hours in each of the studied groups.

  Day 3 of dialysis

Secondary Outcomes (5)

• Time-free of clotting

  Day 3 of dialysis

• Number of dialyzers used

  Day 3 of dialysis

• Pressure variation

  Day 3 of dialysis

• Urea sieving

  Day 3 of dialysis

• Downtime of dialysis

  Day 3 of dialysis

Study Arms (2)

Control group

NO INTERVENTION

Patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l.

Intervention group

EXPERIMENTAL

Patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l associated with unfractionated heparin at 10U / Kg / h.

Drug: unfractionated Heparin

Interventions

unfractionated Heparin DRUG

Addition of unfractioned heparin to CVVHD system already running under citrate regional anticoagulation.

Also known as: No associated drug

Intervention group

Eligibility Criteria

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

You may qualify if:

• Confirmed or probable SARS-CoV-2 infection;
• Presence of acute kidney injury with indication and agreement between ICU and nephrology teams for the introduction of renal continuous venous venous hemodialysis.

You may not qualify if:

• Hypersensitivity to any of the substances used in the study (Citric acid dextrosol 2.2% and unfractionated heparin);
• Previous diagnosis of coagulopathy or thrombophilia;
• Contraindication to the use of unfractionated heparin by the assistant team;
• Risk of citrate poisoning - (Lactate\> 30mg / dL, RNI\> 2.5, Total bilirubin\> 15mg / dL);
• Pregnancy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (2)

• Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

  PMID: 35244208 DERIVED

• Lins PRG, de Albuquerque CCC, Assis CF, Rodrigues BCD, E Siqueira Campos BP, de Oliveira Valle E, Cabrera CPS, de Oliveira Gois J, Segura GC, Strufaldi FL, Mainardes LC, Ribeiro RG, Via Reque Cortes DDP, Lutf LG, de Oliveira MFA, Sales GTM, Smolentzov I, Reichert BV, Andrade L, Seabra VF, Rodrigues CE. Cov-hep study: heparin in standard anticoagulation based on citrate for continuous veno-venous hemodialysis in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Nov 11;21(1):920. doi: 10.1186/s13063-020-04814-0.

  PMID: 33176886 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; COVID-19

Interventions

Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Paulo Lins, MD

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

• Camila Rodrigues, MD, PhD

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial of treatment, randomized-controlled, parallel, open, with two arms

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 27, 2020
• Study Start: June 29, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 3, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)