Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03836742
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2019-02-06
Brief Title:
HEmoFiltration With Citric Acid Anticoagulation
Sponsor:
Medical University of Gdansk
Organization:
Medical University of Gdansk
Study Overview
Official Title:
Evaluation of Safety and Efficacy of a Regional Anticoagulation Protocol for Continuous Renal Replacement Therapies
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEFCAA
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
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 mmolL 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 28 mmolL was adopted In case of pH increase above 75 or bicarbonate concentration above 40 mmolL filtrate flow was decreased from initial 35 mlkghour down to 25 mlkghour 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 2g50 ml 09 NaCl at the flow 1 mLhour
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
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 28 mmolL was adopted In case of pH increase above 75 or bicarbonate concentration above 40 mmolL filtrate flow was decreased from initial 35 mlkghour down to 25 mlkghour 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 2g50 ml 09 NaCl at the flow 1 mLhour
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None