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NCT Number: NCT04865510

Citrate Versus Heparin in Continuous Renal Replacement Therapy :

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

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Key information

Conditions

Acute Kidney Injury Citrate Cytokines Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodynamic Responses Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regional Citrate Anticoagulation

Procedure

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).

Other names: Heparin-free

Primary outcomes

  1. Cardiac output

    Time frame: 72 hour

    cm3/min

  2. Cardiac index

    Time frame: 72 hour

    L/min/m2

  3. Systemic vascular resistance

    Time frame: 72 hour

    mmHg⋅min⋅mL-1

  4. Systemic vascular resistance index

    Time frame: 72 hour

    dynes · sec/cm5/m2

Secondary outcomes

  1. Filter life span

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

    Hours of filter use

  2. Changes of IL-1β

    Time frame: day 1,day 3

    Unit/ml

  3. Changes of IL-6

    Time frame: day 1,day 3

    Unit/ml

  4. Changes of IL-8

    Time frame: day 1,day 3

    Units/ml

  5. Changes of IL-10

    Time frame: day 1,day 3

    Units/mL

  6. Changes of TNF-ɑ

    Time frame: day 1,day 3

    Uniys/mL

  7. Mortality

    Time frame: 28 day

    patient survival

  8. Renal survival

    Time frame: 28 day

    dialysis dependent

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Collaborators

  • Chiang Mai University
  • Department of Medicine, Somdech Phra Pinklao Hospital, Bangkok, Thailand.
  • King Chulalongkorn Memorial Hospital

Registry information

Official study title

Citrate Versus Heparin in Continuous Renal Replacement Therapy : Effect on Cardiovascular System and Clot Circuit in Critically Ill Patients

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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