SepsisPhase 2DEEPNCT05953142
Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
A Phase 2 study testing Dobutamine in people with Sepsis and Hypoperfusion, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hypoperfusion, Hyperlactatemia
- What is being tested?
- Dobutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2024to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of São Paulo
São Paulo, 04038002
Amalia Pinguello, MD, 551155764848, amaliacoelho39@gmail.com
About this study
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.
Read the 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.
- Conditions
- Sepsis, Hypoperfusion, Hyperlactatemia
- Being tested
- Dobutamine
- Keywords
- sepsis, hypoperfusion, dobutamine
- Medical subject headings
- Sepsis, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
Intravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this group will receive the usual treatment according to the Surviving Sepsis Campaign guidelines. |
| Dobutamine | Experimental | Patients in this group will receive, in addition to usual care, dobutamine in continuous infusion for a period of 48 hours after the randomization. Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatine on the third day
Serum creatinine corrected by fluid balance on the third day
Measured: 3 days
Secondary outcomes (6)
ICU mortality
death in the ICU truncated at 60 days
Measured: 60 days
Renal replacement therapy up to day 7
need for renal replacement therapy within the first 7 days after randomization
Measured: 7 days
Hospital mortality
death in the hospital truncated at 60 days
Measured: 60 days
Vasopressors free days up to day 7
Days without vasopressors support within the first 7days after randomization
Measured: 7 days
ICU free days up to day 28th
Days out of the ICU within the first 28 days after randomization
Measured: 28 days
Severe arrhythmia
Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Ribeiro Machado, Federal University of São Paulo
- Investigators
- Amalia Pinguello, MD, Principal investigator, Federal University of São PauloFlavia Machado, PhD, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953142
- Sponsor's protocol ID
- DEEP
- Acronym
- DEEP
- Status last verified
- Jan 2024
- First submitted
- 12 Jul 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: unidentified patients data can be provided upon requested.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
- ClinicalTrials.gov ID
- NCT05953142
- Acronym / sponsor ID
- DEEP / DEEP
- Conditions
- Sepsis, Hypoperfusion, Hyperlactatemia
- Keywords
- sepsis, hypoperfusion, dobutamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this group will receive the usual treatment according to the Surviving Sepsis Campaign guidelines. |
| Dobutamine | Experimental | Drug: DobutaminePatients in this group will receive, in addition to usual care, dobutamine in continuous infusion for a period of 48 hours after the randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DobutamineIntravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization. | Drug | Dobutamine |
Primary outcome
Serum creatine on the third day
Time frame: 3 days
Serum creatinine corrected by fluid balance on the third day
6 secondary outcomes
ICU mortality
Time frame: 60 days
Renal replacement therapy up to day 7
Time frame: 7 days
Hospital mortality
Time frame: 60 days
Vasopressors free days up to day 7
Time frame: 7 days
ICU free days up to day 28th
Time frame: 28 days
Severe arrhythmia
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No. unidentified patients data can be provided upon requested.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amalia Pinguello, MD principal investigator
Federal University of São Paulo
Flavia Machado, PhD, MD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dobutamine in people with Sepsis and Hypoperfusion, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Machado, MD, PhD (+551155764848 ext. 17018, frmachado@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatine on the third day (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.