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

NCT ID: NCT04792424

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-06-15

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?

Conditions

Regional Citrate Anticoagulation; Ionized Calcium; Continuous Renal Replacement Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Regional citrate anticoagulation

Intervention Type: OTHER

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

Vasopressor

Intervention Type: DRUG

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Antibiotic

Intervention Type: DRUG

Antibacterial agents deemed appropriate by physicians in the ICU

Dialysis with continuous renal replacement therapy

Intervention Type: DEVICE

Prismaflex

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.

Group Type: PLACEBO_COMPARATOR

Regional citrate anticoagulation

Intervention Type: OTHER

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

Vasopressor

Intervention Type: DRUG

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Antibiotic

Intervention Type: DRUG

Antibacterial agents deemed appropriate by physicians in the ICU

Dialysis with continuous renal replacement therapy

Intervention Type: DEVICE

Prismaflex

Interventions

Regional citrate anticoagulation

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

Intervention Type: OTHER

Vasopressor

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Intervention Type: DRUG

Antibiotic

Antibacterial agents deemed appropriate by physicians in the ICU

Intervention Type: DRUG

Dialysis with continuous renal replacement therapy

Prismaflex

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Nattachai Srisawat ,M.D.

Director of Excellence Center for Critical Care Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chulalongkorn university

Bangkok, , Thailand

Countries

Thailand

References

Thanapongsatorn P, Sinjira T, Kaewdoungtien P, Kusirisin P, Kulvichit W, Sirivongrangson P, Peerapornratana S, Lumlertgul N, Srisawat N. Standard versus no post-filter ionized calcium monitoring in regional citrate anticoagulation for continuous renal replacement therapy (NPC trial). Clin Kidney J. 2023 Mar 31;16(9):1469-1479. doi: 10.1093/ckj/sfad069. eCollection 2023 Sep.

Reference Type: DERIVED

PMID: 37664560 (View on PubMed)

Other Identifiers

IRB.35/64

Identifier Type: -

Identifier Source: org_study_id