HEmoFiltration With Citric Acid Anticoagulation

Acute Kidney Injury Clinical Trial

— HEFCAA  

Official title:

Evaluation of Safety and Efficacy of a Regional Anticoagulation Protocol for Continuous Renal Replacement Therapies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836742
• Other study ID #: NKBBN/539/2016-17
• Status: Completed
• Start date: August 11, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2019
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Hemofiltration
• Renal Insufficiency
• Renal Replacement Therapy

Intervention

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.

Locations

Country	Name	City	State
Poland	Romuald Lango	Gdansk	Polska

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Kirwan CJ, Hutchison R, Ghabina S, Schwarze S, Beane A, Ramsay S, Thompson E, Prowle JR. Implementation of a Simplified Regional Citrate Anticoagulation Protocol for Post-Dilution Continuous Hemofiltration Using a Bicarbonate Buffered, Calcium Containing Replacement Solution. Blood Purif. 2016;42(4):349-355. Epub 2016 Nov 19. Erratum in: Blood Purif. 2017;43(1-3):144. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemofiltration circuit survival time	in hours	up to 120 hours from the beginning of hemofiltration session
Primary	Incidence of metabolic alkalosis	Arterial blood pH>7.5 or BE > 40 mmol/L	From the beginning of hemofiltration session until 6 hours after its end
Primary	Incidence of hypernatremia and hyponatremia	Incidence of hypernatremia> 150 mmol/L and hyponatremia < 130 mmol/L in arterial blood sample	From the beginning of hemofiltration session until 6 hours after its end
Secondary	Incidence of citrate accumulation	Incidence of total to ionized calcium ratio > 2,5 in arterial blood sample	From the beginning of hemofiltration session until 24 hours after its end