HEFCAA: HEmoFiltration With Citric Acid Anticoagulation

Sponsor
Medical University of Gdansk (Other)
Overall Status
Completed
CT.gov ID
NCT03836742
Collaborator
(none)
54
1
28.7
1.9

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Aug 11, 2015
Actual Primary Completion Date :
Nov 10, 2017
Actual Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Hemofiltration circuit survival time [up to 120 hours from the beginning of hemofiltration session]

    in hours

  2. Incidence of metabolic alkalosis [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Romuald Lango GdaƄsk Polska Poland 80-516

Sponsors and Collaborators

  • Medical University of Gdansk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Feb 11, 2019
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Feb 15, 2019