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

NCT05953142 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DEEP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Hypoperfusion; Hyperlactatemia

Keywords

sepsis; hypoperfusion; dobutamine

Outcome Measures

Primary Outcomes (1)

• Serum creatine on the third day

  Serum creatinine corrected by fluid balance on the third day

  3 days

Secondary Outcomes (6)

• ICU mortality

  60 days

• Renal replacement therapy up to day 7

  7 days

• Hospital mortality

  60 days

• Vasopressors free days up to day 7

  7 days

• ICU free days up to day 28th

  28 days

Study Arms (2)

Control

NO INTERVENTION

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

Dobutamine

EXPERIMENTAL

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

Interventions

Dobutamine DRUG

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

Dobutamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, 04038002, Brazil

Location

MeSH Terms

Conditions

Sepsis; Hyperlactatemia

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Amalia Pinguello, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Flavia Machado, PhD, MD

  Federal University of São Paulo

  STUDY CHAIR

Central Study Contacts

Flavia Machado, MD, PhD

CONTACT

+551155764848; frmachado@unifesp.br

Amalia Pinguello, MD

CONTACT

+551155764848; amaliacoelho39@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Federal University of São Paulo

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 19, 2023
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)