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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05953142
Other study ID # DEEP
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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