Sepsis with Renal Failure MedDRA version: 9.1 Level: LLT Classification code 10040050 Term: Sepsis NOS MedDRA version: 9.1 Level: LLT Classification code 10038435 Term: Renal failure
Conditions
Interventions
Product Name: Alkaline Phosphatase
Product Code: BIAP
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intra
Sponsors
AM-Pharma B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients =18 years and =80 years. • Proven or suspected infection. • Two out of four SIRS criteria of systemic inflammation, as follows: • Core temperature =38° or =36° Celsius. • Heart rate =90 beats/min (unless the patient has a medical condition known to increase heart rate or is receiving treatment that would prevent tachycardia). • Respiratory rate =20 breaths/min, a PaCO2 =32mmHg or the use of mechanical ventilation for an acute respiratory process. • White-cell count =12,000/mm3 or =4,000/mm3 or a differential count showing >10 percent immature neutrophils. • Acute renal failure, defined as - rise in serum creatinine level to =150µmol/L within the previous 48 hours, in the absence of primary underlying renal disease OR - Minimally a stage 1 Kidney Injury according to AKIN criteria: Increase in serum creatinine =26.2 µmol/l (0.3mg/dl) or increase to =150% (=1.5 -fold) from baseline in the previous 48 hours in the absence of primary underlying renal disease and where baseline creatinine is less than 150umol/l OR - minimally a stage 1 Kidney injury according to AKIN Urine Output criteria: Urine Output of = 0.5mg/kg/h for =6 h and following adequate fluid resuscitation when applicable, in the absence of underlying primary renal disease and where baseline creatinine is less than 150umol/l • Written informed consent obtained prior to any study intervention. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • • Pregnant women or nursing mothers and fecund females who are not on effective contraception (chemical: pill; or mechanical: IUD) • Known HIV (sero-positive) patients • Patients already on dialysis (RRT) at entry • Patients receiving immunosuppressant therapy or on chronic high doses of steroids equivalent to prednisone 1mg/Kg/day • Patients expected to have rapidly fatal disease within 24 hours • Known confirmed gram-positive sepsis • Known confirmed fungal sepsis • Acute pancreatitis with no established source of infection • Patients not expected to survive for 28 days due to other medical conditions such as end-stage neoplasm or other diseases • Participation in another investigational study within 90 days prior to start of the study which might interfere with this study • Any previous administration of active study medication. • Known allergy for dairy (bovine) products including cow milk. • Sepsis without renal failure as defined in the Entry Criteria. • History of chronic renal failure or history of persistent creatinine level equal or greater than 150umol/L prior to entry for reasons other than the current sepsis condition".
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirmation of previous trial data on safety and efficacy outcome in septic patients with renal failure: • • To investigate the effect of AP on renal function and associated clinical parameters in sepsis patients with renal failure. • To investigate the safety and tolerability of AP in sepsis patients with renal failure • To investigate the pharmacokinetics of AP in sepsis patients with renal failure • To investigate the effect of AP on inflammatory parameters in sepsis patients with renal failure ;Secondary Objective: not applicable;Primary end point(s): Criteria for Evaluation of Safety • Adverse events • ECG variables • Biochemical safety variables • Hematological variables • Coagulation variables • Serial serum creatinine • Urea / Blood Urea Nitrogen (BUN) • Requirement of Renal Replacement Therapy (RRT) • Duration of RRT • Creatinine clearance • Urinary protein excretion Primary efficacy variables for evaluation of the effect on renal function: • Serum creatinine • Creatinine clearance • Requirement for RRT | — |
Countries
Belgium
Outcome results
None listed