Back to resultsUse of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation. (DEEP)
Primary Purpose
Sepsis, Hypoperfusion, Hyperlactatemia
Status
Not yet recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Dobutamine
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring sepsis, hypoperfusion, dobutamine
Eligibility Criteria
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
Sites / Locations
- Federal University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Dobutamine
Arm Description
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.
Outcomes
Primary Outcome Measures
Serum creatine on the third day
Serum creatinine corrected by fluid balance on the third day
Secondary Outcome Measures
ICU mortality
death in the ICU truncated at 60 days
Renal replacement therapy up to day 7
need for renal replacement therapy within the first 7 days after randomization
Hospital mortality
death in the hospital truncated at 60 days
Vasopressors free days up to day 7
Days without vasopressors support within the first 7days after randomization
ICU free days up to day 28th
Days out of the ICU within the first 28 days after randomization
Severe arrhythmia
Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical)
Full Information
NCT ID
NCT05953142
First Posted
July 12, 2023
Last Updated
July 12, 2023
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05953142
Brief Title
Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
Acronym
DEEP
Official Title
Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Hypoperfusion, Hyperlactatemia
Keywords
sepsis, hypoperfusion, dobutamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group will receive the usual treatment according to the Surviving Sepsis Campaign guidelines.
Arm Title
Dobutamine
Arm Type
Experimental
Arm Description
Patients in this group will receive, in addition to usual care, dobutamine in continuous infusion for a period of 48 hours after the randomization.
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
Intravenous infusion of dobutamine in incremental dosis according to perfusion markers for a period of 48 hours after randomization.
Primary Outcome Measure Information:
Title
Serum creatine on the third day
Description
Serum creatinine corrected by fluid balance on the third day
Time Frame
3 days
Secondary Outcome Measure Information:
Title
ICU mortality
Description
death in the ICU truncated at 60 days
Time Frame
60 days
Title
Renal replacement therapy up to day 7
Description
need for renal replacement therapy within the first 7 days after randomization
Time Frame
7 days
Title
Hospital mortality
Description
death in the hospital truncated at 60 days
Time Frame
60 days
Title
Vasopressors free days up to day 7
Description
Days without vasopressors support within the first 7days after randomization
Time Frame
7 days
Title
ICU free days up to day 28th
Description
Days out of the ICU within the first 28 days after randomization
Time Frame
28 days
Title
Severe arrhythmia
Description
Occurence of severe arrhythmia defined by the need for cardioversion (electric or chemical)
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Machado, MD, PhD
Phone
+551155764848
Ext
17018
Email
frmachado@unifesp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Amalia Pinguello, MD
Phone
+551155764848
Ext
17018
Email
amaliacoelho39@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amalia Pinguello, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flavia Machado, PhD, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04038002
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amalia Pinguello, MD
Phone
551155764848
Email
amaliacoelho39@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
unidentified patients data can be provided upon requested.
Learn more about this trial
Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
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