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

CoV-Hep Study: Randomized and Paired Clinical Trial Comparing Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04487990
Enrollment
118
Registered
2020-07-27
Start date
2020-06-29
Completion date
2021-04-03
Last updated
2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Covid19

Keywords

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

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.

Detailed description

After randomization, patients will be allocated to one of two groups: Control group (n = 45): patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l. The dialysis system pressures, dialyzer patency and duration and bleeding rate will be assessed for 72 hours; Intervention group (n = 45): 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. The dialysis system pressures, dialyzer patency and duration and bleeding rate will be assessed for 72 hours.

Interventions

DRUGunfractionated Heparin

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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Clotted dialyzersDay 3 of dialysisThe percentage of clotted dialyzers within 72 hours in each of the studied groups.

Secondary

MeasureTime frameDescription
Time-free of clottingDay 3 of dialysisNumber of hours until a dialyzer clots in the first 72 hours of dialysis
Number of dialyzers usedDay 3 of dialysisThe amount of dialyzers used in the first 72 hours of hemodialysis
Pressure variationDay 3 of dialysisVariation in dialysis system and vascular access pressures in the first 72 h of dialysis
Urea sievingDay 3 of dialysisVariation in urea sieving between the first, second and third days of dialysis
Downtime of dialysisDay 3 of dialysisTime of dialysis stop due to clotting in the first 72 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026