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

Sepsis Clinical Trial

— DEEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953142
• Other study ID #: DEEP
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: January 2024
• Source: Federal University of São Paulo
• Contact: Flavia Machado, MD, PhD
• Phone: +551155764848
• Email: frmachado[@]unifesp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlactatemia
• Hypoperfusion
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatine on the third day	Serum creatinine corrected by fluid balance on the third day	3 days
Secondary	ICU mortality	death in the ICU truncated at 60 days	60 days
Secondary	Renal replacement therapy up to day 7	need for renal replacement therapy within the first 7 days after randomization	7 days
Secondary	Hospital mortality	death in the hospital truncated at 60 days	60 days
Secondary	Vasopressors free days up to day 7	Days without vasopressors support within the first 7days after randomization	7 days
Secondary	ICU free days up to day 28th	Days out of the ICU within the first 28 days after randomization	28 days
Secondary	Severe arrhythmia	Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical)	7 days