Citrate Versus Heparin in Continuous Renal Replacement Therapy :

Not Applicable

Completed

• Conditions: Cytokines; Hemodynamic Responses; Citrate; Acute Kidney Injury
• Interventions: Procedure: Regional citrate anticoagulation

• Registration Number: NCT04865510
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

Brief Summary

This study is a prospective, multicenter, open-label randomized trial comparing regional citrate anticoagulation (RCA) with heparin-free protocol. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode. The investigators measured hemodynamic changes at certain time points after starting CRRT (0, 6, 12, 24, 48, 72 hr).Levels of inflammatory cytokine (IL-1β, IL-6, IL-8, IL-10 and TNF-ɑ) were measured at day 1 and day 3

Detailed Description

Twenty patients were randomized into heparin group and 11 patients were in citrate group. The cardiac performance were not significantly different between 2 groups at every time point. The inflammatory cytokines declined similarly in both treatment arms. The maximum filter survivial time was longer in a RCA group but not reach statistically significant (44.64±26.56 hr vs p=0.693 in citrate and heparin free group respectively).There was no serious side effects dung both treatment arm even in the group of liver dysfunction patients.

Study Timeline

• Study Start: 2019-02-04
• Primary Completion: 2021-01-15
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-28
• Last Update Submitted: 2021-04-28
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• need for CRRT,
• no contraindication to CRRT

Exclusion Criteria

• patients with previous history of chronic kidney disease (CKD) (baseline serum creatinine > 2 mg/dL (male) or > 1.5 mg/dL (female)
• history of renal transplantation
• known pregnancy
• previous dialysis within 30 days
• severe liver disease
• end stage heart disease or untreatable malignancy
• moribund patients with expected survival less than 30 days
• previous use of heparin or other anticoagulant, antiplatelet within 7 day except use for deep vein thrombosis
• active bleeding at the time of enrollment and/or severe coagulopathy
• receiving blood or blood components prior to enrollment
• hemoglobin less than 7.5 g/dL and/or platelet count less than 100,000/mm3
• previous underlying clotting disorders such as hypercoagulable state
• severe malnutrition (Body mass index (BMI ) less than 18)
• underwent CRRT for other reasons besides acute kidney injury (AKI)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Citrate	Regional citrate anticoagulation	The RCA group CRRT were performed with Prisma flex or (Baxter Healthcare/Gambro Spain) or Informed machine with citrate pump. The function mode was continuous venovenous hemodiafiltration (CVVHDF) in postdilution mode with ST 150 filter sets. The substitution fluid was Accusol or Prismocal B22 .The dose of dialysis was 20-25 ml/kg/hr with blood flow 150-200 ml/min. Trisodium citrate solution (4%,136mmol/L) was infused into the arterial line prior to the blood pump at a dose of 4 mmol/L of plasma flow. Calcium chloride (5% 340 mmol/L elemental calcium) was infused into the venous return to maintain systemic ionized calcium in the normal range (0.99-1.30 mmol/L) and the targets values for ionized calcium (iCa2+) after the dialysis membrane were 0.25-0.35 mmol/L. The rale of calcium infusion was adjusted in a timely manner based on repeated measurements of calcium concentration
Heparin-free	Regional citrate anticoagulation	The heparin- free group The circuit was periodically flushed with 50 ml saline via access limb every 30 minutes .When pre-filter pressure started to rise, additional saline flushes would be given.

Primary Outcome Measures

Name	Time	Method
Cardiac output	72 hour	cm3/min
Systemic vascular resistance	72 hour	mmHg⋅min⋅mL-1
Cardiac index	72 hour	L/min/m2
Systemic vascular resistance index	72 hour	dynes · sec/cm5/m2

Secondary Outcome Measures

Name	Time	Method
Changes of TNF-ɑ	day 1,day 3	Uniys/mL
Filter life span	through study completion,an aveage of 72 hours	Hours of filter use
Changes of IL-6	day 1,day 3	Unit/ml
Renal survival	28 day	dialysis dependent
Changes of IL-10	day 1,day 3	Units/mL
Mortality	28 day	patient survival
Changes of IL-1β	day 1,day 3	Unit/ml
Changes of IL-8	day 1,day 3	Units/ml

Trial Locations

Locations (1)

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University; 🇹🇭 Bangkok, Thailand