Early Goal-directed Therapy and Myocardial Dysfunction

NCT01312688 | Unknown DMC

• 1 other identifier: 0034-11-HMO-CTIL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock; Myocardial Dysfunction

Keywords

Early Goal Directed Hemodunamic Therapy in Sepsis

Outcome Measures

Primary Outcomes (1)

• Survival

  In-ICU, In-hopsital and up to 2-years survival data will be collected and compared between the groups

  2 years

Secondary Outcomes (1)

• Myocardial dysfunction

  5 days

Study Arms (2)

Standard hemodynamic therapy

OTHER

Standard hemodynamic therapy currently accepted in our ICU

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

Other: Early Goal Directed Hemodynamic Therapy in Sepsis

Interventions

Early Goal Directed Hemodynamic Therapy in Sepsis OTHER

Early Goal Directed Hemodynamic Therapy according to the SSC guidelines

Early Goal Directed Hemodynamic Therapy; Standard hemodynamic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Giora Landesberg, MD, DSc

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giora 'Landesberg, MD, DSc

CONTACT

972-54-4512874; gio@cc.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 11, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 11, 2011

Record last verified: 2011-02

Locations

IL (1)