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Trial record 49 of 111 for:    CALCIUM CATION

HEmoFiltration With Citric Acid Anticoagulation (HEFCAA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836742
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Romuald Lango, Medical University of Gdansk

Brief Summary:
Prospective observational study of all consecutive cardio-vascular surgical patients treated with post-dilution hemofiltration with regional citrate anticoagulation as first-choice anticoagulation method. The filter life-span was assessed in the context of postoperative cardiac surgical antithrombotic prophylaxis. Reasons for termination of hemofiltration sessions were assessed. The second aim of this study was to assess the influence ACD-A based anticoagulation protocol on acid-base and ion homeostasis in cardiac surgical patients with acute renal failure.

Condition or disease Intervention/treatment
Acute Kidney Injury Acute Kidney Failure Renal Replacement Therapy Hemofiltration Procedure: Hemofiltration with regional citrate anticoagulation

Detailed Description:

All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation (HF RCA) from August 2015 through November 2017 were included to prospective audit. Indication to hemofiltration treatment was based on clinical assessment of patients renal function and clinical status by attending physician and conformed conventional indications to renal replacement therapy (RRT) in intensive care unit (ICU). Severe chronic liver disease or acute liver injury with INR > 2 and refractory shock with lactate increasing above 8 mmol/L were considered as contraindication to RCA.

Initially set blood flow was 5 times higher than filtrate flow, which makes filtration fraction of 20%. To reduce the risk of metabolic alkalosis, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution, and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which should reduce bicarbonate synthesis by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.

In order to avoid hypomagnesemia resulting from magnesium binding to citrate, and its removal with ultrafiltrate not balanced with magnesium content in replacement fluid, the original protocol was modified by connecting magnesium sulfate solution 2g/50 ml 0.9% NaCl at the flow 1 mL/hour.

All sessions stopped due to patients death before 48 hours of HF treatment were excluded from the analysis. Similarly, all cases where hemofiltration session was stopped before 48 hours of treatment due to organizational reasons, recovery of renal function, change of therapy, and when patients were treated with heparin infusion due to surgical indications were excluded from further circuit survival analysis.

Blood gas parameters together with pH, bicarbonate concentration, Na, Cl, K, Ca, hemoglobin concentration, hematocrit, lactate, and anion gap were analyzed every 6 hours. Post filter ionized calcium concentration was not assessed. Serum phosphate, magnesium and total calcium was assessed every 24 hours during hemofiltration treatment with RCA.

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Safety and Efficacy of a Regional Anticoagulation Protocol for Continuous Renal Replacement Therapies.
Actual Study Start Date : August 11, 2015
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HF RCA
Cardiovascular surgery patients treated with hemofiltration with regional citrate anticoagulation
Procedure: Hemofiltration with regional citrate anticoagulation
To reduce risk of metabolic alkalosis during hemofiltration treatment, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which reduced bicarbonate delivery by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.




Primary Outcome Measures :
  1. Hemofiltration circuit survival time [ Time Frame: up to 120 hours from the beginning of hemofiltration session ]
    in hours

  2. Incidence of metabolic alkalosis [ Time Frame: From the beginning of hemofiltration session until 6 hours after its end ]
    Arterial blood pH>7.5 or BE > 40 mmol/L

  3. Incidence of hypernatremia and hyponatremia [ Time Frame: From the beginning of hemofiltration session until 6 hours after its end ]
    Incidence of hypernatremia> 150 mmol/L and hyponatremia < 130 mmol/L in arterial blood sample


Secondary Outcome Measures :
  1. Incidence of citrate accumulation [ Time Frame: From the beginning of hemofiltration session until 24 hours after its end ]
    Incidence of total to ionized calcium ratio > 2,5 in arterial blood sample



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive cardio-vascular surgery patients treated with post-dilution hemofiltration with regional citrate anticoagulation from August 2015 through November 2017
Criteria

Inclusion Criteria:

  • cardiac and vascular surgery patients treated with continuous hemofiltration with regional citrate anticoagulation

Exclusion Criteria:

  • severe chronic liver disease, acute liver injury with INR > 2, and refractory shock with lactate increasing above 8 mmol/L

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): NCT03836742


Locations
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Poland
Romuald Lango
Gdańsk, Polska, Poland, 80-516
Sponsors and Collaborators
Medical University of Gdansk

Publications:
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Responsible Party: Romuald Lango, Prof. Romuald Lango, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT03836742    
Other Study ID Numbers: NKBBN/539/2016-17
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD are to be shared with other researcher

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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
Additional relevant MeSH terms:
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Calcium Chelating Agents
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action