No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation

Not Applicable

Completed

• Conditions: Regional Citrate Anticoagulation; Ionized Calcium; Continuous Renal Replacement Therapy
• Interventions: Other: Regional citrate anticoagulation; Drug: Vasopressor; Drug: Antibiotic; Device: Dialysis with continuous renal replacement therapy

• Registration Number: NCT04792424
• Lead Sponsor: Chulalongkorn University

Brief Summary

Do no monitor of post-circuit ionized calcium affact the filter life time of continueous renal replacement therapy with regional citrate anticoagulation circuit? A randomized control trial

Detailed Description

Regional citrate anticoagulation is the gold standard of anticoagulation in patient receiving CRRT. In RCA circuit, there was a monitoring of pre-filter (systemic) ionized calcium and post-filter (circuit) ionized calcium. Pre-filter ionized calcium was monitored for observe the adverse effect of citrate such as hypocalcemia, citrate intoxication. However, post-filter ionized calcium was monitored for adjustment the citrate dose. We find many problem with frequently monitoring of post-ionized calcium such as confusion from markedly abnormal result, how to adjustment the citrate dose ,and increase workload for nurses. We hypothesis that if we can monitoring of post-filter ionized calcium?

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-07
• Study First Posted: 2021-03-11
• Study Start: 2021-04-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age older than 18 years old and admission in an ICU
• Indication for CRRT
• regional citrate anticoagulation

Exclusion Criteria

• Acute liver failure defined as AST or ALT > 5X UNL or TB/DB > 5X UNL or evidence of cirrhosis
• Severe persistent lactic acidosis (lactate persist > 8 mg/dL consecutively within 6 hours)
• Receiving heparin anticoagulation
• Severe alkalosis (pH>7.55) or acidosis (pH<7.1)
• History of renal allograft
• Known pregnancy
• Patient is moribund with expected death within 24 hr
• Deficiency of ionzed calcium (Cation < 0.8 mmol/L)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No monitoring of post filter ionized calcium	Dialysis with continuous renal replacement therapy	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
Monitoring of post filter ionized calcium	Dialysis with continuous renal replacement therapy	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
No monitoring of post filter ionized calcium	Regional citrate anticoagulation	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
Monitoring of post filter ionized calcium	Regional citrate anticoagulation	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
Monitoring of post filter ionized calcium	Vasopressor	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
No monitoring of post filter ionized calcium	Vasopressor	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
No monitoring of post filter ionized calcium	Antibiotic	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L and no adjustment of citrate dose. Post-filter ionized calcium result will blind for physician. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.
Monitoring of post filter ionized calcium	Antibiotic	Starting dialysis with continuous renal replacement therapy with regional citrate anticoagulation. Patients will receive standard treatments such as anti-bacterial agents, mechanical ventilator, vasopressors as appropriate. Citrate dose start at 4 mmol/L with adjustment of citrate dose to acheive post-filter ionized calcium at 0.25-0.35 mmol/L. Other laboratory such as pre-filter ionized calcium, electrolyte, ABG, calcium, the ratio of total calcium to systemic ionized calcium will monitor every 8 hour.

Primary Outcome Measures

Name	Time	Method
Filter lifetime in hours	72 hours	How long with filter with RCA

Secondary Outcome Measures

Name	Time	Method
Adverse event	72 hours	adverse event of RCA
Circuit downtime in hours	72 hours	Circuit downtime during CRRT with RCA
Cost per treatment in Baht	72 hour	Cost of CRRT include laboratory in Baht
Citrate accumulation	72 hours	Number of total calcium to ionized calcium ratio \> 2.5
Efficacy of CRRT	72 hours	Seiving coefficient of urea and difference of prescribed dose of CRRT
Citrate dose	72 hours	Average citrate dose

Trial Locations

Locations (1)

Chulalongkorn university; 🇹🇭 Bangkok, Thailand