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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04792424
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Regional Citrate Anticoagulation; Ionized Calcium; Continuous Renal Replacement Therapy	Other: Regional citrate anticoagulation; Drug: Vasopressor; Drug: Antibiotic; Device: Dialysis with continuous renal replacement therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Masking Description: Masking of post-filter ionized calcium result in no-monitoring arm
• Primary Purpose: Treatment
• Official Title: No Monitoring of Post-filter Ionized Calcium in Regional Citrate Anticoagulation
• Actual Study Start Date: Apr 1, 2021
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Jun 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Filter lifetime in hours [72 hours]

   How long with filter with RCA

Secondary Outcome Measures

1. Adverse event [72 hours]

   adverse event of RCA

2. Circuit downtime in hours [72 hours]

   Circuit downtime during CRRT with RCA

3. Cost per treatment in Baht [72 hour]

   Cost of CRRT include laboratory in Baht

4. Citrate accumulation [72 hours]

   Number of total calcium to ionized calcium ratio > 2.5

5. Efficacy of CRRT [72 hours]

   Seiving coefficient of urea and difference of prescribed dose of CRRT

6. Citrate dose [72 hours]

   Average citrate dose

Other Outcome Measures

1. Change of SOFA scores [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 [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 [72 hours]

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

4. Change of electrolyte [72 hours]

   Rate of electrolyte change from baseline to end of the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chulalongkorn university	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nattachai Srisawat ,M.D., Director of Excellence Center for Critical Care Nephrology, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04792424
• Other Study ID Numbers: IRB No.35/2564
• First Posted: Mar 11, 2021
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nattachai Srisawat ,M.D., Director of Excellence Center for Critical Care Nephrology, Chulalongkorn University: Regional citrate anticoagulation; Ionized calcium; Continuous Renal Replacement Therapy
• Additional relevant MeSH terms: Anti-Bacterial Agents; Vasoconstrictor Agents

Study Results

No Results Posted as of Jun 21, 2022