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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05953142

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Hypoperfusion Hyperlactatemia	Drug: Dobutamine	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Patients in this group will receive the usual treatment according to the Surviving Sepsis Campaign guidelines.
Experimental: 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.	Drug: Dobutamine Intravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization.

Arm

Intervention/Treatment

No Intervention: Control

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

Experimental: 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.

Drug: Dobutamine

Intravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization.

Outcome Measures

Primary Outcome Measures

Serum creatine on the third day [3 days]
Serum creatinine corrected by fluid balance on the third day

Secondary Outcome Measures

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
Vasopressors free days up to day 7 [7 days]
Days without vasopressors support within the first 7days after randomization
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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