A Phase 2 interventional study of Dobutamine in Sepsis, Hypoperfusion and Hyperlactatemia, sponsored by Federal University of São Paulo. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Federal University of São Paulo · Phase 2, Interventional, and Treatment
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 120 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will receive the usual treatment according to the Surviving Sepsis Campaign guidelines.
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
Intravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization.
Serum creatine on the third day
Serum creatinine corrected by fluid balance on the third day
Time frame: 3 days
ICU mortality
death in the ICU truncated at 60 days
Time frame: 60 days
Renal replacement therapy up to day 7
need for renal replacement therapy within the first 7 days after randomization
Time frame: 7 days
Hospital mortality
death in the hospital truncated at 60 days
Time frame: 60 days
Vasopressors free days up to day 7
Days without vasopressors support within the first 7days after randomization
Time frame: 7 days
ICU free days up to day 28th
Days out of the ICU within the first 28 days after randomization
Time frame: 28 days
Severe arrhythmia
Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical)
Time frame: 7 days
Plan to share: No — unidentified patients data can be provided upon requested.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dobutamine
Federal University of São Paulo →