Clinical trial NCT05953142: Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
Official title: Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Sepsis
Hypoperfusion
Hyperlactatemia
Keywords: sepsis
hypoperfusion
dobutamine
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum creatine on the third day
timeFrame: 3 days
Secondary outcomes:
measure: ICU mortality
timeFrame: 60 days
measure: Renal replacement therapy up to day 7
timeFrame: 7 days
measure: Hospital mortality
timeFrame: 60 days
measure: Vasopressors free days up to day 7
timeFrame: 7 days
measure: ICU free days up to day 28th
timeFrame: 28 days
measure: Severe arrhythmia
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Amalia Pinguello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Flavia Machado, PhD, MD
role: STUDY_CHAIR
References: