Monitoring Resuscitation in Severe Sepsis and Septic Shock

NCT01747057 | Unknown DMC

• 1 other identifier: MORESS
• Study Type: interventional
• Target: 952
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Mortality at 28 days

  28 days after hospital admission

Secondary Outcomes (8)

• 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)

Study Arms (2)

Dynamic guide resuscitation

EXPERIMENTAL

This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management.

Behavioral: Dynamic-parameters-guided fluid management

Standard resuscitation

ACTIVE COMPARATOR

This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations.

Behavioral: Standard-guided-fluid management

Interventions

Dynamic-parameters-guided fluid management BEHAVIORAL

● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation\* and with sinus rhythm. 1. PPV \>12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ \[(PPmax+PPmin)/2\] x100 (during 5 respiratory cycles) 2. SVV \> 12% (15). SVV: Stroke volume variation * A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed. Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV \< 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP\>12). ● Non-preload responsive patients (defined as PPV or SVV \< 12%) will resume the same protocol as responders when fluid response parameters are negative.

Dynamic guide resuscitation

Standard-guided-fluid management BEHAVIORAL

Fluid loading in patients with hypotension or elevated lactates until normalization of MAP (\> 65mmHg) or CVP \> 12mmHg. If CVP reaches \> 12 mmHg and MAP remains \< 65mmHg, norepinephrine should be started to reach MAP \> 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output \< 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC\>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning.

Standard resuscitation

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 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.
• Tachycardia (HR \> 110 bpm) or bradycardia (HR \< 55 bpm)
• Acute onset of oliguria, defined as a decreased urine output \< 0.5 ml/kg/hr for ≥ 2 hours
• Serum lactate \> 2 mmol/l
• Peripheral cyanosis, mottled skin, prolonged capillary refill
• Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau \< 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains \< 30 mmH2O.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Area de Critics. Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

RECRUITING

Central Study Contacts

Xaime Garcia, MD

CONTACT

+34937231010; xgarcia@tauli.cat

Gisela Gili, RN

CONTACT

+34937231010; ggilis@tauli.cat

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: Director of Critical Care Area

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 11, 2012
• Study Start: March 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

ES (1)