Status:
COMPLETED
Co-administration of Iloprost and Eptifibatide in Septic Shock Patients
Lead Sponsor:
Sisse R. Ostrowski, MD PhD DMSc
Conditions:
Septic Shock
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Objective Evaluating the safety and efficacy of iloprost and eptifibatide co-administration compared to placebo as an addition to standard care in septic shock patients. Trial rationale Iloprost and ...
Eligibility Criteria
Inclusion
- Adult intensive care patients (age ≥18 years) AND
- Sepsis, defined as suspected or confirmed site of infection or positive blood culture and ≥2 of 4 systemic inflammatory response syndrome (SIRS) criteria fulfilled within the last 24h:
- Temperature ≤ 36˚ C or ≥ 38˚C
- Heart rate ≥ 90 beats per minute
- Mechanical ventilation for acute respiratory process or respiratory rate ≥ 20 breaths per minute or PaCO2 \< 4.2 kPa
- WBC ≥ 12,000/mm³ OR ≤ 4,000/mm³ OR \> 10% bands AND
- Septic shock within the last 24h, defined as:
- Hypotension (MAP \<70 mmHg, Lactate 4 mmol/L) despite ongoing resuscitation with fluids (crystalloids, colloids, blood products) within the last 24h OR
- ≥30 ml/kg ideal body weight (IBW) fluid (crystalloids, colloids, blood products) given in the last 24h AND
- Need for vasopressor/inotropic agents (noradrenaline, adrenaline, dopamine) within the last 24h AND
- Can be randomized into trial and dosed \< 24h after septic shock diagnosis (the time-point for the septic shock diagnosis corresponds to the time-point where the vasopressor/inotropic therapy (3c) is initiated) AND
- Consent is obtainable
Exclusion
- Patient is pregnant or breast-feeding
- Patient weights more than 125 kg
- Patients with known allergy towards any of the investigational products or contraindications which should be excluded according to the investigational product specifications
- Patients in whom the clinician finds antithrombotic therapy contraindicated - prophylaxis included
- Patients at increased risk of bleeding:
- Surgery in the previous 48h and expected surgery within 48 h
- Epidural or spinal puncture in the previous 12h
- Platelet count less than 10,000/mm3 in the previous 24h
- Need of blood products for bleeding in the previous 24h (3 or more RBC/24 h)
- Treatment with any antithrombotics within 12h (profylaxis excepted)
- Current intracranial bleeding
- Traumatic brain or spinal injury within the last month
- Patients requiring any form of antithrombotics (beyond profylaxis) in therapeutic doses or prothrombotics in any dose, including:
- Unfractionated heparin within 8h before the infusion (prophylactic heparin up to 15,000 U/day permitted)
- LMWH within 12h before the infusion (prophylactic doses permitted)
- Warfarin within 1 day before the infusion
- Acetylsalicylic acid more than 650 mg/day within 3 days before the study
- Thrombolytic therapy within 3 days before the study (catheter clearance doses permitted)
- GPIIb/IIIa receptor inhibitors within 4 days before the study
- Antithrombin III with dose greater than 10,000 U within 12h before the study
- Patients with a do-not-resuscitate order (expected not to survive more than few days because of uncorrectable medical or surgical condition other than sepsis)
- Patient with chronic renal failure requiring dialysis (renal failure without need for dialysis permitted)
- Patients who have undergone transplantation of bone marrow, liver, pancreas, heart, lung, or bowel (kidney transplant permitted)
- Patient with known hypercoagulable condition:
- Activated protein C resistance
- Hereditary protein C, protein S, or antithrombin III deficiency
- Anticardiolipin or antiphospholipid antibody
- Lupus anticoagulant
- Homocysteinemia
- Recent or highly suspected pulmonary embolism or deep venous thrombosis (within 3 months)
- Patients with known congenital hypocoagulable diseases
- Patient with known primary pulmonary hypertension
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02204852
Start Date
September 1 2014
End Date
August 1 2016
Last Update
April 24 2017
Active Locations (1)
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1
Department of Anesthesia and Intensive Care, Nordsjællands Hospital
Hillerød, Capital Region, Denmark, DK-3400