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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04792424
Enrollment
50
Registered
2021-03-11
Start date
2021-04-01
Completion date
2022-06-15
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Citrate Anticoagulation, Ionized Calcium, Continuous Renal Replacement Therapy

Keywords

Regional citrate anticoagulation, Ionized calcium, Continuous Renal Replacement Therapy

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?

Interventions

Starting RCA 4 mmol/L (adjust the rate by BFR)

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

DRUGAntibiotic

Antibacterial agents deemed appropriate by physicians in the ICU

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

Masking of post-filter ionized calcium result in no-monitoring arm

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Filter lifetime in hours72 hoursHow long with filter with RCA

Secondary

MeasureTime frameDescription
Circuit downtime in hours72 hoursCircuit downtime during CRRT with RCA
Cost per treatment in Baht72 hourCost of CRRT include laboratory in Baht
Citrate accumulation72 hoursNumber of total calcium to ionized calcium ratio \> 2.5
Efficacy of CRRT72 hoursSeiving coefficient of urea and difference of prescribed dose of CRRT
Citrate dose72 hoursAverage citrate dose
Adverse event72 hoursadverse event of RCA

Other

MeasureTime frameDescription
Change of Hct72 hoursRate of Hct change from from baseline to end of the study
Change of electrolyte72 hoursRate of electrolyte change from baseline to end of the study
Change of APACHE II score72 hoursChange of APACHE II score (Use the worst value in 24 hour)from baseline to end of the study
Change of SOFA scores72 hoursChange of SOFA Scores (Use the worst value in 24 hour) from baseline to end of the study

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026