Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resu… (NCT05953142) | Clinical Trial Compass
UnknownPhase 2
Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
Brazil120 participantsStarted 2024-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial, which means it's still in relatively early stages of testing — what does that mean for what's currently known about the safety of using dobutamine in sepsis patients like me who still have signs of poor blood flow after initial fluid resuscitation?
2The trial is mainly measuring serum creatinine on day three, which is a marker of kidney function — can you explain why kidney function is the key thing being watched here, and what it would mean for me if my creatinine levels changed during treatment?
3The recruitment status for this trial is listed as unknown, so can you find out whether this study is actually still enrolling patients and whether it's available at a facility I could realistically get to, especially given that sepsis care often happens urgently?
4Since dobutamine is a drug that strengthens heart pumping, and this trial is testing it specifically in sepsis patients who still have hypoperfusion after fluids, how would the medical team decide whether my heart and circulation are in the right condition for this approach versus standard sepsis management?
5Are there already established treatments for sepsis with ongoing hyperlactatemia and poor perfusion that I should consider first, and how does the potential benefit of joining this experimental trial compare to those standard options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.