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
|Condition or disease||Intervention/treatment|
|Acute Kidney Injury Acute Kidney Failure Renal Replacement Therapy Hemofiltration||Procedure: Hemofiltration with regional citrate anticoagulation|
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 Type :||Observational|
|Actual Enrollment :||54 participants|
|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|
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.
- Hemofiltration circuit survival time [ Time Frame: up to 120 hours from the beginning of hemofiltration session ]in hours
- 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
- 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
- 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
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
|Gdańsk, Polska, Poland, 80-516|