Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Regional Anticoagulation With Citrate in Extended Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297839
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
InCor Heart Institute
Hospital do Cancer, Sao Paulo
Information provided by (Responsible Party):
EMMANUEL DE ALMEIDA BURDMANN, University of Sao Paulo General Hospital

Brief Summary:

Data on regional citrate anticoagulation in patients with acute kidney injury (AKI) treated by hybrid or extended dialysis are scarce and heterogeneous. The path batch system (Genius®) or the proportion hemodialysis machines are well suited equipments to perform extended dialysis. However, clotting of the system might occur with relatively high frequency, especially in critically ill patients with high risk of clotting or in those with contraindication to the use of heparin.

The aims of this study are: 1) to test and to validate a new protocol using citrate to perform regional anticoagulation in AKI patients admitted to the intensive care unit (ICU) and treated by extended dialysis, using a control group (use of heparin or intermittent saline flush) as comparison in the Heart Institute of the university medical complex "Clinics Hospital Medical School at São Paulo" (Hospital das Clínicas da Faculdade de Medicina do Estado de São Paulo) and at the Cancer Institute of the São Paulo State; 2) to evaluate the anticoagulation in these procedures with citrate and compare with the control group using heparin or saline flush, so the primary end point would be the rates of system clotting; 3) to study the calcium mass transfer in these procedures and its impact on bone metabolism in these patients. The inclusion criteria are all AKI patients admitted in these places and candidates to renal replacement therapy using the extended dialysis, age above 18 years. The exclusion criteria are acute liver failure, hemorrhagic stroke, platelets level below 20,000/mm3, and active bleeding needing transfusional support (two or more red cell packs in 24 hours).


Condition or disease Intervention/treatment Phase
Hemodialysis Complication Acute Kidney Injury Anticoagulant Toxicity Drug: Citrate Anticoagulation Solution Drug: Control Group (heparin or continuous saline) Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open label randomized clinical trial with cross-over between the groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Regional Anticoagulation With Citrate in Extended Hemodialysis in Patients With Acute Renal Injury Admitted to an Intensive Care Unit
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group

Patients in this group will receive heparin during hemodialysis sessions, at a dose of 1.000 units at the beginning and 500 units per hour in a syringe infusion pump.

If the patient has a contraindication for the heparin use, it will receive saline continuous administration.

This is the actual standard of care performed in extended hemodialysis sessions.

Drug: Control Group (heparin or continuous saline)
Use of heparin in hemodialysis sessions. If there is any contraindication against the use of heparina, the investigators will perform saline flush of the dialysis system
Other Names:
  • Heparin
  • Saline

Experimental: Citrate Group
Patients in this group will receive regional citrate anticoagulation, with acid-citrate-dextrose 2.2% (ACD). Dose of 3 mmol per liter of filtered blood. The systemic calcium levels are measured every two hours and a solution of calcium chloride is infused in a peripheral venous access, accordingly to citrate infusion rate and the systemic calcium values.
Drug: Citrate Anticoagulation Solution
Regional citrate anticoagulation in extended hemodialysis sessions compared to the standard of care actually performed in these therapies (heparin or continuous saline infusion)
Other Name: Citrate




Primary Outcome Measures :
  1. Clotting rate [ Time Frame: through all dialysis session, an average of 8 hours ]
    Clotting of the dialysis system with complete impossibility to continue the therapy


Secondary Outcome Measures :
  1. Parathyroid hormone (PTH), Fibroblast growth factor-23 (FGF-23), Procollagen type 1 N-terminal propeptide (P1NP), Esclerostin and Telopeptide carboxiterminal of type I collagen (cTX) [ Time Frame: through all dialysis session, an average of 8 hours ]
    Serum hormone levels will be evaluated before the dialysis session

  2. Dialysate calcium [ Time Frame: through all dialysis session, an average of 8 hours ]
    Dialysate calcium will be evaluated to address the calcium balance

  3. Serum ionized and total calcium levels [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours.

  4. Serum sodium concentration [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours.

  5. Serum potassium concentration [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours.

  6. Serum bicarbonate [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session. In the citrate group it will be measured every 2 hours.

  7. Serum phosphorus [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session.

  8. Serum magnesium [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session.

  9. Serum creatinine concentration [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session.

  10. Serum urea concentration [ Time Frame: through all dialysis session, an average of 8 hours ]
    Measurement before and after the dialysis session.

  11. Parathyroid hormone (PTH) concentration [ Time Frame: two measurements per patient (before the dialysis initiation and at the end, after an average of 8 hours) ]
    Serum hormone levels will be evaluated before the dialysis session

  12. Fibroblast growth factor-23 (FGF-23) concentration [ Time Frame: baseline, before the dialysis initiation ]
    Serum hormone levels will be evaluated before the dialysis session

  13. Procollagen type 1 N-terminal propeptide (P1NP) concentration [ Time Frame: baseline, before the dialysis initiation ]
    Serum hormone levels will be evaluated before the dialysis session

  14. Sclerostin concentration [ Time Frame: baseline, before the dialysis initiation ]
    Serum hormone levels will be evaluated before the dialysis session

  15. Telopeptide carboxyterminal of type I collagen (cTX) concentration [ Time Frame: baseline, before the dialysis initiation ]
    Serum hormone levels will be evaluated before the dialysis session

  16. Mean arterial pressure [ Time Frame: every hour in the dialysis session (an average of 8 hours) ]
    Patients in dialysis will have their blood pressure recorded every hour

  17. Heart rate [ Time Frame: every hour in the dialysis session (an average of 8 hours) ]
    Patients in dialysis will have their heart rate recorded every hour

  18. Respiratory rate [ Time Frame: every hour in the dialysis session (an average of 8 hours) ]
    Patients in dialysis will have their respiratory rate recorded every hour

  19. Temperature [ Time Frame: every hour in the dialysis session (an average of 8 hours) ]
    Patients in dialysis will have their temperature rate recorded every hour



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • All patients with acute kidney injury admitted to the intensive care unit and candidates for extended dialysis (renal replacement therapy)
  • Age over 18 years.

Exclusion Criteria:

  • Acute liver failure
  • Hemorrhagic stroke in the last 30 days
  • Patients with platelet levels below 20,000/mm3
  • Active bleeding requiring transfusion (two or more red blood cell packs within 24 hours)

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): NCT04297839


Contacts
Layout table for location contacts
Contact: Emmanuel Burdmann, PhD +55(11)30618317 burdmann@usp.br
Contact: Lucas Mota, MD +55(11)981063076 lucasbraga3@gmail.com

Locations
Layout table for location information
Brazil
University of São Paulo Medical School Recruiting
São Paulo, Brazil, 01246903
Contact: Emmanuel Burdmann, PhD    +55(11)30618317    burdmann@usp.br   
Contact: Lucas Braga Mota, MD    +55(11)981063076    lucasbraga3@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
InCor Heart Institute
Hospital do Cancer, Sao Paulo
Layout table for additonal information
Responsible Party: EMMANUEL DE ALMEIDA BURDMANN, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04297839    
Other Study ID Numbers: 6293
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The researchers have hot decided yet about this issue

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by EMMANUEL DE ALMEIDA BURDMANN, University of Sao Paulo General Hospital:
Extended Hemodialysis
Anticoagulation
Citrate
Heparin
Coagulation in Dialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heparin
Calcium heparin
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents