Acute Kidney Injury, Citrate, Cytokines, Hemodynamic Responses
Conditions
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.
Interventions
PROCEDURERegional citrate anticoagulation
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).
Sponsors
King Chulalongkorn Memorial Hospital
Chiang Mai University
Department of Medicine, Somdech Phra Pinklao Hospital, Bangkok, Thailand.
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
systemic random sampling (block of four). Group A was the citrate group while group B was heparin- free method.
Intervention model description
This study is a prospective,multicenter, open-label randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output | 72 hour | cm3/min |
| Cardiac index | 72 hour | L/min/m2 |
| Systemic vascular resistance | 72 hour | mmHg⋅min⋅mL-1 |
| Systemic vascular resistance index | 72 hour | dynes · sec/cm5/m2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of IL-10 | day 1,day 3 | Units/mL |
| 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 |
| Renal survival | 28 day | dialysis dependent |
| Mortality | 28 day | patient survival |
| Changes of IL-1β | day 1,day 3 | Unit/ml |
| Changes of IL-6 | day 1,day 3 | Unit/ml |
| Changes of IL-8 | day 1,day 3 | Units/ml |
Countries
Thailand
Outcome results
None listed