NCT04792424

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

March 3, 2021

Last Update Submit

November 9, 2022

Conditions

Regional Citrate AnticoagulationIonized CalciumContinuous Renal Replacement Therapy

Keywords

Regional citrate anticoagulationIonized calciumContinuous Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

  • Filter lifetime in hours

    How long with filter with RCA

    72 hours

Secondary Outcomes (6)

  • Adverse event

    72 hours

  • Circuit downtime in hours

    72 hours

  • Cost per treatment in Baht

    72 hour

  • Citrate accumulation

    72 hours

  • Efficacy of CRRT

    72 hours

  • +1 more secondary outcomes

Other Outcomes (4)

  • Change of SOFA scores

    72 hours

  • Change of APACHE II score

    72 hours

  • Change of Hct

    72 hours

  • +1 more other outcomes

Study Arms (2)

No monitoring of post filter ionized calcium

EXPERIMENTAL

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 anticoagulationDrug: VasopressorDrug: AntibioticDevice: Dialysis with continuous renal replacement therapy

Monitoring of post filter ionized calcium

PLACEBO COMPARATOR

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 anticoagulationDrug: VasopressorDrug: AntibioticDevice: Dialysis with continuous renal replacement therapy

Interventions

Regional citrate anticoagulationOTHER

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

Monitoring of post filter ionized calciumNo monitoring of post filter ionized calcium
VasopressorDRUG

Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine

Monitoring of post filter ionized calciumNo monitoring of post filter ionized calcium
AntibioticDRUG

Antibacterial agents deemed appropriate by physicians in the ICU

Monitoring of post filter ionized calciumNo monitoring of post filter ionized calcium
Dialysis with continuous renal replacement therapyDEVICE

Prismaflex

Monitoring of post filter ionized calciumNo monitoring of post filter ionized calcium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 18 years old and admission in an ICU
  • Indication for CRRT
  • regional citrate anticoagulation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn university

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 37664560DERIVED

MeSH Terms

Interventions

Vasoconstrictor AgentsAnti-Bacterial AgentsDialysisContinuous Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesAnti-Infective AgentsChemistry Techniques, AnalyticalInvestigative TechniquesChemical PhenomenaRenal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Masking of post-filter ionized calcium result in no-monitoring arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Excellence Center for Critical Care Nephrology

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 11, 2021

Study Start

April 1, 2021

Primary Completion

May 30, 2022

Study Completion

June 15, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

TH(1)