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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05953142
Study type Interventional
Source Federal University of São Paulo
Contact Flavia Machado, MD, PhD
Phone +551155764848
Email frmachado@unifesp.br
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2024
Completion date March 31, 2026

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