SepsisSEPT-MDNCT01312688
Early Goal-directed Therapy and Myocardial Dysfunction
A study testing Early Goal Directed Hemodynamic Therapy in Sepsis in people with Sepsis and Septic Shock, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The cardiovascular system plays a central role in the pathophysiology and prognosis of sepsis, yet the correct hemodynamic management of septic patients is still vigorously debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate prediction of fluid requirement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Myocardial Dysfunction
- What is being tested?
- Early Goal Directed Hemodynamic Therapy in Sepsis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intensive care unit patients with severe sepsis or septic shock, age 18 or above.
Who cannot join
- Pregnant women
- Patients with known significant valvular or coronary heart disease
- Patients with poor quality echocardiography imaging
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Center
Jerusalem, 91120
Giora Landesberg, 972-54-4512874
About this study
Official title: The Effect Early Goal-directed Therapy on Myocardial Dysfunction and Survival in ICU Patients With Severe Sepsis and Septic Shock: A Prospective Randomized Controlled Trial
The cardiovascular system plays a central role in the pathophysiology and prognosis of sepsis, yet the correct hemodynamic management of septic patients is still vigorously debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate prediction of fluid requirement. Recently studies showed that early goal-directed therapy (EGDT) aimed at achieving a ScvO2 of ≥70% significantly improved survival of septic shock patients, yet EGDT has not been adopted by all intensivists. The investigators have recently found using 2D echocardiography in 262 patients with severe sepsis or septic shock and treated by the conventional guidelines (without ScvO2) that diastolic dysfunction and reduced stroke volume index are strong independent predictors of mortality. In the present study the investigators intend to test the effect of EGDT on resuscitation, on long term myocardial function and left ventricular volumes and on survival in ICU patients with severe sepsis and septic shock. Patients will be randomized to EGDT (resuscitation directed by ScvO2) or standard of therapy for the first six hours after diagnosis of severe sepsis or septic shock and admission to the ICU. After six hours patients in septic shock will be further monitored with non invasive cardiac output (PiCCO, Pulsion Technologies). All patients will be followed daily by 2D \& 3D transthoracic echocardiography with detailed measurements of systolic and diastolic left and right ventricular volumes and functions. Patients in the EGDT group will be compared to the control group for parameters of initial resuscitation (fluid volumes, ScvO2 achieved, inotrope use), initial values from non invasive cardiac output at six hours, interventions required from institution of non invasive cardiac output, early and long term effects on cardiac function and volumes from echo measurements, and mortality. The effectiveness of EGDT will thus be examined in the short and long terms.
Read the detailed description
Design: Prospective randomized controlled trial, approved (now submitted for approval) by the Institutional Review Board. Over a period of 2 years, 300 patients with severe sepsis or septic shock will be randomized to either the currently accepted standard hemodynamic treatment in our ICU or to the standard plus goal-directed therapy according to the Rivers protocol and the SSC guidelines, i.e. including the addition of ScvO2 measurements and consequently derived treatments to achieve ScvO2 ≥70% for the first 6 hours after appearance of sepsis or septic shock in the ICU (Fig. 2).
After the first 6 hours all patients in septic shock (62% of the patients according to our preliminary data) will be monitored by continuous cardiac output monitoring. Additionally, all patients will be followed daily by transthoracic echocardiography for up 19 to 5 days (Fig 3). Since the patients themselves will not be able to sign an informed consent, the inclusion to the study will be approved by the attending physician in charge of the ICU who will also be able to decide on stopping the study protocol at any time according to his clinical judgment as to the best interest of the patient.
- Conditions
- Sepsis, Septic Shock, Myocardial Dysfunction
- Being tested
- Early Goal Directed Hemodynamic Therapy in Sepsis
- Keywords
- Early Goal Directed Hemodunamic Therapy in Sepsis
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Goal Directed Hemodynamic Therapy in SepsisOther
Early Goal Directed Hemodynamic Therapy according to the SSC guidelines
| Study group | Role | What they receive |
|---|---|---|
| Standard hemodynamic therapy | Other | Standard hemodynamic therapy currently accepted in our ICU Receives: Other: Early Goal Directed Hemodynamic Therapy in Sepsis |
| Early Goal Directed Hemodynamic Therapy | Experimental | Early Goal Directed Hemodynamic Therapy according to the Surviving Sepsis Campaign Guidelines Receives: Other: Early Goal Directed Hemodynamic Therapy in Sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
In-ICU, In-hopsital and up to 2-years survival data will be collected and compared between the groups
Measured: 2 years
Secondary outcomes (1)
Myocardial dysfunction
Systolic and diastolic myocardial function will be measured by echocardiography daily in the first 5 days of treatment and compared between the groups
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Giora Landesberg, MD, DSc, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312688
- Sponsor's protocol ID
- 0034-11-HMO-CTIL
- Acronym
- SEPT-MD
- Status last verified
- Feb 2011
- First submitted
- 1 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Early Goal-directed Therapy on Myocardial Dysfunction and Survival in ICU Patients With Severe Sepsis and Septic Shock: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01312688
- Acronym / sponsor ID
- SEPT-MD / 0034-11-HMO-CTIL
- Conditions
- Sepsis, Septic Shock, Myocardial Dysfunction
- Keywords
- Early Goal Directed Hemodunamic Therapy in Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Mar 2011 (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 cardiovascular system plays a central role in the pathophysiology and prognosis of sepsis, yet the correct hemodynamic management of septic patients is still vigorously debated. Despite guidelines, the use of CVP and PAOP is seriously criticized for inaccurate prediction of fluid requirement. Recently studies showed that early goal-directed therapy (EGDT) aimed at achieving a ScvO2 of ≥70% significantly improved survival of septic shock patients, yet EGDT has not been adopted by all intensivists. The investigators have recently found using 2D echocardiography in 262 patients with severe sepsis or septic shock and treated by the conventional guidelines (without ScvO2) that diastolic dysfunction and reduced stroke volume index are strong independent predictors of mortality. In the present study the investigators intend to test the effect of EGDT on resuscitation, on long term myocardial function and left ventricular volumes and on survival in ICU patients with severe sepsis and septic shock. Patients will be randomized to EGDT (resuscitation directed by ScvO2) or standard of therapy for the first six hours after diagnosis of severe sepsis or septic shock and admission to the ICU. After six hours patients in septic shock will be further monitored with non invasive cardiac output (PiCCO, Pulsion Technologies). All patients will be followed daily by 2D \& 3D transthoracic echocardiography with detailed measurements of systolic and diastolic left and right ventricular volumes and functions. Patients in the EGDT group will be compared to the control group for parameters of initial resuscitation (fluid volumes, ScvO2 achieved, inotrope use), initial values from non invasive cardiac output at six hours, interventions required from institution of non invasive cardiac output, early and long term effects on cardiac function and volumes from echo measurements, and mortality. The effectiveness of EGDT will thus be examined in the short and long terms.
Detailed description
Design: Prospective randomized controlled trial, approved (now submitted for approval) by the Institutional Review Board. Over a period of 2 years, 300 patients with severe sepsis or septic shock will be randomized to either the currently accepted standard hemodynamic treatment in our ICU or to the standard plus goal-directed therapy according to the Rivers protocol and the SSC guidelines, i.e. including the addition of ScvO2 measurements and consequently derived treatments to achieve ScvO2 ≥70% for the first 6 hours after appearance of sepsis or septic shock in the ICU (Fig. 2).
After the first 6 hours all patients in septic shock (62% of the patients according to our preliminary data) will be monitored by continuous cardiac output monitoring. Additionally, all patients will be followed daily by transthoracic echocardiography for up 19 to 5 days (Fig 3). Since the patients themselves will not be able to sign an informed consent, the inclusion to the study will be approved by the attending physician in charge of the ICU who will also be able to decide on stopping the study protocol at any time according to his clinical judgment as to the best interest of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard hemodynamic therapy | Other | Other: Early Goal Directed Hemodynamic Therapy in SepsisStandard hemodynamic therapy currently accepted in our ICU |
| Early Goal Directed Hemodynamic Therapy | Experimental | Other: Early Goal Directed Hemodynamic Therapy in SepsisEarly Goal Directed Hemodynamic Therapy according to the Surviving Sepsis Campaign Guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intensive care unit patients with severe sepsis or septic shock, age 18 or above.
Key exclusion criteria (3 listed)
- Pregnant women
- Patients with known significant valvular or coronary heart disease
- Patients with poor quality echocardiography imaging
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 |
|---|---|---|
| Early Goal Directed Hemodynamic Therapy in SepsisEarly Goal Directed Hemodynamic Therapy according to the SSC guidelines | Other | Early Goal Directed Hemodynamic Therapy, Standard hemodynamic therapy |
Primary outcome
Survival
Time frame: 2 years
In-ICU, In-hopsital and up to 2-years survival data will be collected and compared between the groups
1 secondary outcome
Myocardial dysfunction
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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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.
Giora Landesberg, MD, DSc principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Goal Directed Hemodynamic Therapy in Sepsis in people with Sepsis and Septic Shock, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 3 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 11 Mar 2011. 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 Israel. 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.
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 Giora 'Landesberg, MD, DSc (972-54-4512874, gio@cc.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 2 years). 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 11 Mar 2011.