Citrate Versus Heparin in Continuous Renal Replacement Therapy :

Bangkok Metropolitan Administration Medical College and Vajira Hospital41 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Kidney Injury Citrate Cytokines

Interventions

Regional citrate anticoagulationPROCEDURE

The investigators collected patient's plasma at study start (day 0) and at day 3, 5, 7, 14, 28) .Samples were used to measure inflammatory markers (Il 6, IL 8, IL 10 and TNFα) . . Markers of dialysis efficiency (BUN, creatinine) and other parameters related to AKI (acid base status, calcium, phosphorus, hemoglobin). The recorded variables also included adverse events, dialysis clotting, hemodynamic status, duration of mechanical ventilation, inotropic support. The hemodynamic parameters were monitored by EV 1000 clinical platform .The investigators measured cardiac performance data, which includes cardiac output (CO), cardiac index (CI), stroke volume (SV), and stroke volume indexes (SVI). Moreover, it also provides information about systemic vascular resistance (SVR). Thus, patient hemodynamic parameters as mentioned above were measured at the following 6 time-point: after the initiation of CRRT (T1), every 6 hours later for 24 hours (T2, T3, T4, T5), and at hour-72 (T6).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Cardiac output

cm3/min

Time frame: 72 hour

Cardiac index

L/min/m2

Time frame: 72 hour

Systemic vascular resistance

mmHg⋅min⋅mL-1

Time frame: 72 hour

Systemic vascular resistance index

dynes · sec/cm5/m2

Time frame: 72 hour

Secondary Outcomes

Filter life span

Hours of filter use

Time frame: through study completion,an aveage of 72 hours

Changes of IL-1β

Unit/ml

Time frame: day 1,day 3

Changes of IL-6

Unit/ml

Time frame: day 1,day 3

Changes of IL-8

Units/ml

Time frame: day 1,day 3

Changes of IL-10

Units/mL

Time frame: day 1,day 3

Changes of TNF-ɑ

Uniys/mL

Time frame: day 1,day 3

Mortality

patient survival

Time frame: 28 day

Renal survival

dialysis dependent

Time frame: 28 day

Citrate Versus Heparin in Continuous Renal Replacement Therapy :

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes