Resuscitation Strategies in Septic Shock

NCT02150512 | Unknown

• 1 other identifier: ReSSeS-2014
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study, in mechanically ventilated septic shock patients, is to determine whether a fluid loading strategy based on parameters derived from the transpulmonary thermodilution technique may lead to more ventilator free days compared to a fluid loading strategy based on the surviving sepsis guidelines.

Conditions

Septic Shock; Critically Ill

Keywords

Septic shock; Critically ill patients; Transpulmonary thermodilution; Fluid resuscitation

Outcome Measures

Primary Outcomes (1)

• ventilator free days (VFDs)

  VFDs from enrolment to extubation until day 28

  28 days

Secondary Outcomes (1)

• duration of circulatory shock (hours)

  72 hours

Other Outcomes (4)

• mortality

  30 days and 90 days

• RIFLE-F score

  5 days

• fluid balance

  5 days

Study Arms (2)

Transpulmonary thermodilution (TPTD)

EXPERIMENTAL

The intervention group (TPTD guided therapy) follows a fluid resuscitation protocol based on stroke volume variation (SVV) and extravascular lung water (EVLW). Initial trigger for fluid loading when circulatory insufficiency is present will be SVV.

Device: Transpulmonary Thermodilution

Surviving Sepsis Guidelines (SSG)

ACTIVE COMPARATOR

The standard group (SSG guided therapy) follows a fluid resuscitation protocol based on the Surviving Sepsis Campaign recommendations. Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg).

Device: Surviving Sepsis Guidelines (SSG)

Interventions

Transpulmonary Thermodilution DEVICE

Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. If SVV ≤10% in patients on controlled mechanical ventilation with tidal volumes of ≥8 ml/kg, fluid loading will not be performed. If SVV \>10% or spontaneous breathing efforts are present, a fluid challenge should be performed. Also if patients are on controlled mechanical ventilation with tidal volumes of ≤7 ml/kg, a fluid challenge should be performed. If fluid responsiveness is present and SVV decreases to ≤10%, further fluid loading should be stopped. If SVV is still \>10%, the increase in EVLW will decide whether to continue fluid loading or not; if EVLW is ≥12 mL/kg PBW and EVLW increases upon fluid loading, further fluid loading should be stopped.

Also known as: PiCCO, Pulsion Medical Systems, Germany

Transpulmonary thermodilution (TPTD)

Surviving Sepsis Guidelines (SSG) DEVICE

Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). If circulatory insufficiency is absent, fluid loading will not be initiated or stopped independently of the actual CVP level.

Surviving Sepsis Guidelines (SSG)

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Clinical evidence of sepsis (microbiology confirmation, radiological or direct view (pus in biological fluid) or direct surgical view).
• ≥ 2 SIRS criteria:
• Temperature \< 36.0°C or \> 38.0°C
• Heart rate \> 90 bpm
• Respiratory rate \> 20 rpm or PaCO2 \< 4.2 kPa or need of mechanical ventilation.
• Leukocytes \> 12.0 x109/L or \< 4.0 x109/L or \>10% bands
• Circulatory shock defined as sustained systemic hypotension (systolic arterial pressure \<90 mmHg or MAP \<65 mmHg (\<75 mmHg in a hypertensive patient) despite a 1,000 ml IV fluid challenge over 30 min (including IV fluids administered pre-ICU) or the need for vasopressor therapy. Hypertensive patients are patients with a history of confirmed hypertension treated with antihypertensive agents.
• Mechanical ventilation by endotracheal tube (any form)

You may not qualify if:

• Pregnancy
• Pre-terminal illness with life expectancy \<28 days
• Duration of circulatory shock \>6 hours
• Severe peripheral arterial vascular occlusion disease (Fontaine level III-IV)
• Inability for femoral artery canulation
• No informed consent

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• RJ Trof, MD PhD

  Medisch Spectrum Twente, department of Intensive Care

  PRINCIPAL INVESTIGATOR

• A Beishuizen, MD PhD

  Medisch Spectrum Twente, department of Intensive Care

  STUDY DIRECTOR

Central Study Contacts

RJ Trof, MD PhD

CONTACT

0031-53-4872000; r.trof@mst.nl

M Burgmeijer

CONTACT

0053-4872000; researchIC@mst.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 30, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

NL (1)