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

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ClinicalTrials.gov Identifier: NCT04487990
Recruitment Status : Active, not recruiting
First Posted : July 27, 2020
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Covid19 Drug: unfractionated Heparin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial of treatment, randomized-controlled, parallel, open, with two arms
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CoV-Hep Study: Randomized and Paired Clinical Trial Comparing Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19
Actual Study Start Date : June 29, 2020
Actual Primary Completion Date : March 31, 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l.
Experimental: Intervention group
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
Addition of unfractioned heparin to CVVHD system already running under citrate regional anticoagulation.
Other Name: No associated drug




Primary Outcome Measures :
  1. Clotted dialyzers [ Time Frame: Day 3 of dialysis ]
    The percentage of clotted dialyzers within 72 hours in each of the studied groups.


Secondary Outcome Measures :
  1. Time-free of clotting [ Time Frame: Day 3 of dialysis ]
    Number of hours until a dialyzer clots in the first 72 hours of dialysis

  2. Number of dialyzers used [ Time Frame: Day 3 of dialysis ]
    The amount of dialyzers used in the first 72 hours of hemodialysis

  3. Pressure variation [ Time Frame: Day 3 of dialysis ]
    Variation in dialysis system and vascular access pressures in the first 72 h of dialysis

  4. Urea sieving [ Time Frame: Day 3 of dialysis ]
    Variation in urea sieving between the first, second and third days of dialysis

  5. Downtime of dialysis [ Time Frame: Day 3 of dialysis ]
    Time of dialysis stop due to clotting in the first 72 hours



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487990


Locations
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Brazil
University of São Paulo General Hospital
São Paulo, SP, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Paulo Lins, MD University of São Paulo General Hospital
Principal Investigator: Camila Rodrigues, MD, PhD University of São Paulo General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04487990    
Other Study ID Numbers: U1111-1252-0194
33351120.0.0000.0068 ( Other Identifier: CAAE / CONEP / CEP )
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Sao Paulo General Hospital:
acute kidney injury
continuous venovenous hemodialysis
anticoagulation
heparin
citrate
covid-19
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action