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

Continuous Renal Replacement Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792424
• Other study ID #: IRB.35/64
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2022
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 15, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Continuous Renal Replacement Therapy
• Ionized Calcium
• Regional Citrate Anticoagulation

Intervention

Other:
• Regional citrate anticoagulation
Starting RCA 4 mmol/L (adjust the rate by BFR)

Drug:
• Vasopressor
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
• Antibiotic
Antibacterial agents deemed appropriate by physicians in the ICU

Device:
• Dialysis with continuous renal replacement therapy
Prismaflex

Locations

Country	Name	City	State
Thailand	Chulalongkorn university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of SOFA scores	Change of SOFA Scores (Use the worst value in 24 hour) from baseline to end of the study	72 hours
Other	Change of APACHE II score	Change of APACHE II score (Use the worst value in 24 hour)from baseline to end of the study	72 hours
Other	Change of Hct	Rate of Hct change from from baseline to end of the study	72 hours
Other	Change of electrolyte	Rate of electrolyte change from baseline to end of the study	72 hours
Primary	Filter lifetime in hours	How long with filter with RCA	72 hours
Secondary	Adverse event	adverse event of RCA	72 hours
Secondary	Circuit downtime in hours	Circuit downtime during CRRT with RCA	72 hours
Secondary	Cost per treatment in Baht	Cost of CRRT include laboratory in Baht	72 hour
Secondary	Citrate accumulation	Number of total calcium to ionized calcium ratio > 2.5	72 hours
Secondary	Efficacy of CRRT	Seiving coefficient of urea and difference of prescribed dose of CRRT	72 hours
Secondary	Citrate dose	Average citrate dose	72 hours