Monitoring Resuscitation in Severe Sepsis and Septic Shock

Corporacion Parc Tauli1 site in 1 country952 target enrollmentMarch 2013

ConditionsHemodynamics

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hemodynamics
Sponsor: Corporacion Parc Tauli
Enrollment: 952
Locations: 1
Primary Endpoint: Mortality at 28 days
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.

Detailed Description

To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

May 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Corporacion Parc Tauli

Responsible Party

Principal Investigator

Antonio Artigas Raventós

Director of Critical Care Area

Corporacion Parc Tauli

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years
•Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
•≥ 2 SIRS criteria:
•Temperature \< 36.0°C or \> 38.0°C
•Heart rate \> 90 bpm
•Respiratory rate \> 20 rpm or PaCO2 \< 32 mmHg or need of mechanical ventilation.
•Leukocytes \> 12.0 x109/L or \< 4.0 x109/L
•Hemodynamic insufficiency defined as (at least one of the following):
•Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP \< 65 mmHg) or a decrease in MAP of \> 30 mm Hg in a hypertensive patient.
•Need of vasopressors.

Exclusion Criteria

•Acute myocardial infarction \< 7 days.
•Pregnancy
•Prior request of limited code status or expected life length lower than 3 months.
•Shock \> 12h
•Cardiac arrhythmia
•Aortic valvular disease
•Inability to properly measure arterial pressure wave forms

Outcomes

Primary Outcomes

Mortality at 28 days

Time Frame: 28 days after hospital admission

Secondary Outcomes

Length of resuscitation(72 hours after protocol inclusion)
Ventilator-free days(28 days after admission)
Vasopressor-free days(28 days after admission)
Organ failure-free days(28 days after admission)
ICU length of stay(At ICU discharge (expected average 30 days after admission))
Hospital length of stay(At hospital discharge (expected average 45 days after hospital admission))
Renal function evolution(3 days after study enrollment)
Mortality at 3 months(3 months after admission)