Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.

DEEP

This phase 2 study aim to investigate the effect of dobutamine in patients with sepsis/ septic shock after fluid resuscitation and with hypoperfusion (lactate and central venous oxygen saturation or prolonged capillary refill time) on renal function as compared with usual care.

2024-02-01

2025-12-31

2026-03-31

Not yet recruiting

Early phase I

120

Inclusion Criteria: * Over 18 years old * Patient with sepsis (suspected or confirmed) for less than 48 hours with: Adequate volume resuscitation with 30 ml/kg of crystalloid solution or assessment by the attending physician that fluid resuscitation is no longer indicated Signs of hypoperfusion for less than 12 hours assessed by arterial lactate over two times the reference value and central venous saturation (SvcO2) less than 66% OR capillary refill time greater than 3 seconds. Exclusion Criteria: * Pregnancy * Risk of imminent death within the next 12 hours in the opinion of the attending physician * Patients under end of live care * Previous congestive heart failure in functional class IV and/or dependence for all basic activities of daily living * Hemoglobin levels below 7.0 g/dL * Current use of dobutamine * Patients in renal replacement therapy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-01-30