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

Study Overview
=================
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?

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

Conditions
-----------------
Regional Citrate Anticoagulation, Ionized Calcium, Continuous Renal Replacement Therapy

Intervention / Treatment
-----------------
* Other: Regional citrate anticoagulation
* Drug: Vasopressor
* Drug: Antibiotic
* Device: Dialysis with continuous renal replacement therapy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No monitoring of post filter ionized calcium<br>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<br>* Starting RCA 4 mmol/L (adjust the rate by BFR)<br>Drug: Vasopressor<br>* Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine<br>Drug: Antibiotic<br>* Antibacterial agents deemed appropriate by physicians in the ICU<br>Device: Dialysis with continuous renal replacement therapy<br>* Prismaflex<br>|
| Placebo Comparator: Monitoring of post filter ionized calcium<br>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<br>* Starting RCA 4 mmol/L (adjust the rate by BFR)<br>Drug: Vasopressor<br>* Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine<br>Drug: Antibiotic<br>* Antibacterial agents deemed appropriate by physicians in the ICU<br>Device: Dialysis with continuous renal replacement therapy<br>* Prismaflex<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regional citrate anticoagulation, Ionized calcium, Continuous Renal Replacement Therapy