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Completed

NCT Number: NCT04792424

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

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

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Key information

Conditions

Regional Citrate Anticoagulation Continuous Renal Replacement Therapy Ionized Calcium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn university

Bangkok, 10330, Thailand

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regional citrate anticoagulation

Other

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

Vasopressor

Drug

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Antibiotic

Drug

Antibacterial agents deemed appropriate by physicians in the ICU

Dialysis with continuous renal replacement therapy

Device

Prismaflex

Primary outcomes

  1. Filter lifetime in hours

    Time frame: 72 hours

    How long with filter with RCA

Secondary outcomes

  1. Adverse event

    Time frame: 72 hours

    adverse event of RCA

  2. Circuit downtime in hours

    Time frame: 72 hours

    Circuit downtime during CRRT with RCA

  3. Cost per treatment in Baht

    Time frame: 72 hour

    Cost of CRRT include laboratory in Baht

  4. Citrate accumulation

    Time frame: 72 hours

    Number of total calcium to ionized calcium ratio > 2.5

  5. Efficacy of CRRT

    Time frame: 72 hours

    Seiving coefficient of urea and difference of prescribed dose of CRRT

  6. Citrate dose

    Time frame: 72 hours

    Average citrate dose

Other outcomes

  1. Change of SOFA scores

    Time frame: 72 hours

    Change of SOFA Scores (Use the worst value in 24 hour) from baseline to end of the study

  2. Change of APACHE II score

    Time frame: 72 hours

    Change of APACHE II score (Use the worst value in 24 hour)from baseline to end of the study

  3. Change of Hct

    Time frame: 72 hours

    Rate of Hct change from from baseline to end of the study

  4. Change of electrolyte

    Time frame: 72 hours

    Rate of electrolyte change from baseline to end of the study

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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