Early Goal-directed Therapy and Myocardial Dysfunction (SEPT-MD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312688
Recruitment Status : Unknown
Verified February 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2011
Last Update Posted : March 11, 2011
Information provided by:
Hadassah Medical Organization

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Myocardial Dysfunction Other: Early Goal Directed Hemodynamic Therapy in Sepsis Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Standard hemodynamic therapy
Standard hemodynamic therapy currently accepted in our ICU
Other: Early Goal Directed Hemodynamic Therapy in Sepsis
Early Goal Directed Hemodynamic Therapy according to the SSC guidelines

Experimental: Early Goal Directed Hemodynamic Therapy
Early Goal Directed Hemodynamic Therapy according to the Surviving Sepsis Campaign Guidelines
Other: Early Goal Directed Hemodynamic Therapy in Sepsis
Early Goal Directed Hemodynamic Therapy according to the SSC guidelines

Primary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]
    In-ICU, In-hopsital and up to 2-years survival data will be collected and compared between the groups

Secondary Outcome Measures :
  1. Myocardial dysfunction [ Time Frame: 5 days ]
    Systolic and diastolic myocardial function will be measured by echocardiography daily in the first 5 days of treatment and compared between the groups

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Intensive care unit patients with severe sepsis or septic shock, age 18 or above.

Exclusion Criteria:

  • Pregnant women
  • Patients with known significant valvular or coronary heart disease
  • Patients with poor quality echocardiography imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312688

Contact: Giora `Landesberg, MD, DSc 972-54-4512874

Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Giora Landesberg    972-54-4512874      
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Giora Landesberg, MD, DSc Hadassah Medical Organization

Responsible Party: Giora Landesberg MD, DSc, Hadassah Medical Center Identifier: NCT01312688     History of Changes
Other Study ID Numbers: 0034-11-HMO-CTIL
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: February 2011

Keywords provided by Hadassah Medical Organization:
Early Goal Directed Hemodunamic Therapy in Sepsis

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes