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

November 9, 2022 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: No monitoring of post filter ionized calcium

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.
Other: Regional citrate anticoagulation
Starting RCA 4 mmol/L (adjust the rate by BFR)
Drug: Vasopressor
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
Drug: Antibiotic
Antibacterial agents deemed appropriate by physicians in the ICU
Device: Dialysis with continuous renal replacement therapy
Prismaflex
PLACEBO_COMPARATOR: Monitoring of post filter ionized calcium

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.
Other: Regional citrate anticoagulation
Starting RCA 4 mmol/L (adjust the rate by BFR)
Drug: Vasopressor
Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
Drug: Antibiotic
Antibacterial agents deemed appropriate by physicians in the ICU
Device: Dialysis with continuous renal replacement therapy
Prismaflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Filter lifetime in hours
Time Frame: 72 hours
How long with filter with RCA
72 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours
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
72 hours
Change of Hct
Time Frame: 72 hours
Rate of Hct change from from baseline to end of the study
72 hours
Change of electrolyte
Time Frame: 72 hours
Rate of electrolyte change from baseline to end of the study
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

May 30, 2022

Study Completion (ACTUAL)

June 15, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (ACTUAL)

March 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB.35/64

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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