Acute renal failure MedDRA version: 16.0 Level: LLT Classification code 10001041 Term: Acute renal failure System Organ Class: 100000004857
Conditions
Interventions
Product Name: Solution A
Product Code: 6040083
Pharmaceutical Form: Solution for haemodialysis/haemofiltration
INN or Proposed INN: SODIUM CHLORIDE
CAS Number: 7647-14-5
Concentration unit: mmol/l mil
Sponsors
Gambro Lundia AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Stable patients treated with CRRT at the study site. •Patients with stabile homeostasis two hours before the inclusion. •Patients with a well-functioning dialysis catheter. •Informed consent to participate in the study by the patient or the relative. •Patients aged 18 years or more. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •Participation in other studies during the study period which may affect the outcome of the present study. •Patients dependent on chronic dialysis. •Patients that do not reach stability two hours before the study start. •CRRT during less than 10 hours. •Patients with HIV and/or hepatitis B and C. •Persons under guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to achieve anticoagulation (i.e. an ionized calcium concentration of about 0.3 mM (0.2-0.5 mM) in the extracorporeal circuit during the novel citrate therapy.;Secondary Objective: The secondary objectives are: 1. Maintain calcium homeostasis during the CRRT treatment 2. Maintain physiological levels of calcium and magnesium and avoid acid-base disturbances 3. To investigate plasma levels of citrate with the present treatment ;Primary end point(s): The anticoagulation effect will be assessed by measuring if achieving ionized calcium concentration of about 0.3 mM (0.2-0.5 mM) in the extracorporeal circuit during the novel citrate therapy.;Timepoint(s) of evaluation of this end point: Continuous during the 5 hours of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of maintained calcium homeostasis during the CRRT treatment by measuring ionized and total calcium concentrations. Evaluation of maintained magnesium concentration during the CRRT treatment by measuring total magnesium concentration. Evaluation of acid-base balance from blood gas analysis. Investigation of plasma levels of citrate by measuring citrate concentration.;Timepoint(s) of evaluation of this end point: Continuous during the 5 hours of treatment | — |
Countries
Sweden
Contacts
Public ContactTherapeutic Fluid Research
Gambro Lundia
Outcome results
None listed