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

NCT ID: NCT05953142

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-03-31

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.

Conditions

Sepsis; Hypoperfusion; Hyperlactatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Dobutamine

Intervention Type: DRUG

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

Interventions

Dobutamine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Flavia Ribeiro Machado

Federal University of São Paulo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amalia Pinguello, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Flavia Machado, PhD, MD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, , Brazil

Countries

Brazil

Central Contacts

Flavia Machado, MD, PhD

Role: CONTACT

frmachado@unifesp.br

+551155764848 ext. 17018

Amalia Pinguello, MD

Role: CONTACT

amaliacoelho39@gmail.com

+551155764848 ext. 17018

Facility Contacts

Amalia Pinguello, MD

Role: primary

amaliacoelho39@gmail.com

551155764848

Other Identifiers

DEEP

Identifier Type: -

Identifier Source: org_study_id