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

Federal University of São Paulo

Status and phase: Not yet enrolling; Phase 2

Conditions: Hyperlactatemia; Hypoperfusion; Sepsis

Treatments: Drug: Dobutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05953142

DEEP

Details and patient eligibility

About

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.

Full description

In this phase 2 study patients with sepsis/ septic shock and signs of persistent hypoperfusion after fluid resuscitation will be randomized to receive either dobutamine or no intervention in addition to usual care. Dobutamine will be used for 48 hours. Hypoperfusion will be assessed by altered lactate levels and a low SvO2 or prolonged capillary refill time. Both arms will receive usual care according to the Surviving Sepsis Campaign guidelines. Dobutamine dosis will be adjusted to achieve improvement in the perfusion parameters according to a pre specified protocol. Pre specified criteria will be used to stop the drug for safety. The primary outcome will be creatinine at Day 3. Other secondary and safety outcomes will also be assessed.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control

No Intervention group

Description:

Patients in this group will receive the usual treatment according to the Surviving Sepsis Campaign guidelines.

Dobutamine

Experimental group

Description:

Patients in this group will receive, in addition to usual care, dobutamine in continuous infusion for a period of 48 hours after the randomization.

Treatment:

Drug: Dobutamine