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

Phase 2

Not yet recruiting

• Conditions: Hyperlactatemia; Sepsis; Hypoperfusion
• Interventions: Drug: Dobutamine

• Registration Number: NCT05953142
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Study Start: 2024-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum creatine on the third day	3 days	Serum creatinine corrected by fluid balance on the third day

Secondary Outcome Measures

Name	Time	Method
Vasopressors free days up to day 7	7 days	Days without vasopressors support within the first 7days after randomization
ICU mortality	60 days	death in the ICU truncated at 60 days
Renal replacement therapy up to day 7	7 days	need for renal replacement therapy within the first 7 days after randomization
Hospital mortality	60 days	death in the hospital truncated at 60 days
ICU free days up to day 28th	28 days	Days out of the ICU within the first 28 days after randomization
Severe arrhythmia	7 days	Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical)

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil