Hyperlactatemia, Hypoperfusion, Sepsis
Conditions
Keywords
sepsis, hypoperfusion, dobutamine
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.
Interventions
DRUGDobutamine
Intravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatine on the third day | 3 days | Serum creatinine corrected by fluid balance on the third day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal replacement therapy up to day 7 | 7 days | need for renal replacement therapy within the first 7 days after randomization |
| Hospital mortality | 60 days | death in the hospital truncated at 60 days |
| ICU mortality | 60 days | death in the ICU truncated at 60 days |
| ICU free days up to day 28th | 28 days | Days out of the ICU within the first 28 days after randomization |
| Severe arrhythmia | 7 days | Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical) |
| Vasopressors free days up to day 7 | 7 days | Days without vasopressors support within the first 7days after randomization |
Countries
Brazil
Contacts
Primary ContactFlavia Machado, MD, PhD
Backup ContactAmalia Pinguello, MD
Outcome results
None listed