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CoV-Hep study : Comparative study between different anti-coagulation strategies in continuous hemodialysis in COVID-19 patients

CoV-Hep study: Randomized and paired clinical trial comparing regional anticoagulation modalities in continuous venous venous hemodialysis in patients with COVID-19

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-45kf9p
Enrollment
Unknown
Registered
2020-07-13
Start date
2020-06-29
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Acute Kidney Injury Severe COVID-19

Interventions

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 anticoagu
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 unfractio
Drug
E02.870.150

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women aged 18 and over; 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

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, IRN> 2.5, Total bilirubin> 15mg / dL); Pregnancy

Design outcomes

Primary

MeasureTime frame
The percentage of clotted dialyzers within 72 hours in each of the studied groups. Anticoagulation with citrate + heparin is expected to lead to a lower percentage of clotted dialyzers than anticoagulation with citrate alone, in 72 hours of therapy.

Secondary

MeasureTime frame
Expected outcome #1 Number of hours until a dialyzer clots in the first 72 hours of dialysis; Anticoagulation with citrate alone is expected to lead to dialyzer clotting earlier than in anticoagulation with citrate + heparin.;Expected outcome #2 Amount of dialyzers used in the first 72 hours of hemodialysis; It is expected that anticoagulation with citrate alone will lead to the need of a greater amount of dialyzers in 72 hours than in anticoagulation with citrate + heparin.;Expected outcome #3 Variation in dialysis system and vascular access pressures in the first 72 hours of hemodialysis; Anticoagulation with citrate alone is expected to lead to higher system and access pressures than with anticoagulation with citrate + heparin.;Expected outcome #4 Variation in the removal of urea (urea from the dialysate / blood urea) between the first, second and third days of dialysis; Anticoagulation with citrate + heparin is expected to lead to higher rates of urea removal, with less difference between therapy days, than anticoagulation with citrate alone.;Expected outcome #5 Downtime of dialysis due to clotting in the first 72 hours. Anticoagulation with citrate alone is expected to lead to longer downtime due to system clotting compared to anticoagulation with citrate + heparin.

Countries

Brazil

Contacts

Public ContactCamila;Paulo Eleuterio Rodrigues;Gessolo Lins

Hospital das Clínicas da FMUSP;Hospital das Clínicas da FMUSP

camila.eleuterio@hc.fm.usp.br;paulo.lins@hc.fm.usp.br+5511945428122;+5511982792696

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 25, 2026