Severe SepsisNCT02794025
The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
A study testing Esmolol and natural saline in people with Severe Sepsis, run by Fujian Provincial Hospital.
Trial summary
The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Esmolol and natural saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2013
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years;
- severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
- mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
- satisfactory sedation and analgesic treatment, with HR > 100 bpm.
Who cannot join
- pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
- acute or chronic pulmonary heart disease;
- a history of serious asthma;
- chronic renal insufficiency;
- cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
- insulin-dependent diabetes.
About this study
Official title: The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .
The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis
Read the detailed description
enrollment:151 patients
Inclusion criteria: (1) age > 18 years; (2) severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR > 100 bpm.
- Conditions
- Severe Sepsis
- Being tested
- Esmolol, natural saline
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called β-blockers
patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. The initial dose was 0.05 mg/kg/min and was adjusted based on heart rate (HR) (target HR: 70 bpm < HR < 100 bpm within 72 hours).
Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.
natural salineDrug
Control group also received natural saline via a micro pump,
| Study group | Role | What they receive |
|---|---|---|
| esmolol group | Experimental | patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. Receives: Drug: Esmolol |
| control group | Sham comparator | Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol. Receives: Drug: natural saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuling Shang, Fujian Provincial Hospital
- Investigators
- Rongguo Yu, MD, Study director, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794025
- Sponsor's protocol ID
- K2010-001-01
- Status last verified
- Jun 2016
- First submitted
- 4 Jun 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 151 patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76)
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .
- ClinicalTrials.gov ID
- NCT02794025
- Acronym / sponsor ID
- K2010-001-01
- Conditions
- Severe Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis
Detailed description
enrollment:151 patients
Inclusion criteria: (1) age > 18 years; (2) severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR > 100 bpm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esmolol group | Experimental | Drug: Esmololpatients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. |
| control group | Sham comparator | Drug: natural salineControl group also received natural saline via a micro pump, in the same way the esmolol group received esmolol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years;
- severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
- mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
- satisfactory sedation and analgesic treatment, with HR > 100 bpm.
Key exclusion criteria (6 listed)
- pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
- acute or chronic pulmonary heart disease;
- a history of serious asthma;
- chronic renal insufficiency;
- cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
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 |
|---|---|---|
| EsmololAlso: β-blockerspatients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. The initial dose was 0.05 mg/kg/min and was adjusted based on heart rate (HR) (target HR: 70 bpm < HR < 100 bpm within 72 hours). Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol. | Drug | esmolol group |
| natural salineControl group also received natural saline via a micro pump, | Drug | control group |
Primary outcome
The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Individual participant dataSharing planned: Yes. 151 patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76)
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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.
Rongguo Yu, MD study director
Fujian Provincial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol and natural saline in people with Severe Sepsis, run by Fujian Provincial Hospital.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death. (time frame: 28 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 8 Jun 2016.