Acute Kidney InjuryNCT04487990
CoV-Hep Study: Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19
A study testing unfractionated Heparin in people with Acute Kidney Injury and Covid19, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Covid19
- What is being tested?
- unfractionated Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jun 2020to 3 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo General Hospital
São Paulo, São Paulo, 05403-010
About this study
Official title: CoV-Hep Study: Randomized and Paired Clinical Trial Comparing Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Covid19
- Being tested
- unfractionated Heparin
- Keywords
- acute kidney injury, continuous venovenous hemodialysis, anticoagulation, heparin, citrate, covid-19
- Medical subject headings
- Acute Kidney Injury, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unfractionated HeparinDrug
Also called No associated drug
Addition of unfractioned heparin to CVVHD system already running under citrate regional anticoagulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotted dialyzers
The percentage of clotted dialyzers within 72 hours in each of the studied groups.
Measured: Day 3 of dialysis
Secondary outcomes (5)
Time-free of clotting
Number of hours until a dialyzer clots in the first 72 hours of dialysis
Measured: Day 3 of dialysis
Number of dialyzers used
The amount of dialyzers used in the first 72 hours of hemodialysis
Measured: Day 3 of dialysis
Pressure variation
Variation in dialysis system and vascular access pressures in the first 72 h of dialysis
Measured: Day 3 of dialysis
Urea sieving
Variation in urea sieving between the first, second and third days of dialysis
Measured: Day 3 of dialysis
Downtime of dialysis
Time of dialysis stop due to clotting in the first 72 hours
Measured: Day 3 of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start29 Jun 2020
- Primary completion31 Mar 2021
- Study completion3 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial of treatment, randomized-controlled, parallel, open, with two arms
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulo Lins, MD, Principal investigator, University of São Paulo General HospitalCamila Rodrigues, MD, PhD, Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487990
- Sponsor's protocol ID
- U1111-1252-0194
- Other IDs
- 33351120.0.0000.0068
- Status last verified
- Jun 2022
- First submitted
- 23 Jul 2020
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Lins 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.
PubMed 33176886
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoV-Hep Study: Randomized and Paired Clinical Trial Comparing Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04487990
- Acronym / sponsor ID
- U1111-1252-0194
- Conditions
- Acute Kidney Injury, Covid19
- Keywords
- acute kidney injury, continuous venovenous hemodialysis, anticoagulation, heparin, citrate, covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 3 Apr 2021 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical trial of treatment, randomized-controlled, parallel, open, with two arms
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: unfractionated HeparinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unfractionated HeparinAlso: No associated drugAddition of unfractioned heparin to CVVHD system already running under citrate regional anticoagulation. | Drug | Intervention group |
Primary outcome
Clotted dialyzers
Time frame: Day 3 of dialysis
The percentage of clotted dialyzers within 72 hours in each of the studied groups.
5 secondary outcomes
Time-free of clotting
Time frame: Day 3 of dialysis
Number of dialyzers used
Time frame: Day 3 of dialysis
Pressure variation
Time frame: Day 3 of dialysis
Urea sieving
Time frame: Day 3 of dialysis
Downtime of dialysis
Time frame: Day 3 of dialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 35244208Flumignan 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33176886Lins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Lins, MD principal investigator
University of São Paulo General Hospital
Camila Rodrigues, MD, PhD principal investigator
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unfractionated Heparin in people with Acute Kidney Injury and Covid19, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clotted dialyzers (time frame: Day 3 of dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487990, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.