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Monitoring Resuscitation in Severe Sepsis and Septic Shock

This study is not yet open for participant recruitment.
Verified December 2012 by Corporacion Parc Tauli
Sponsor:
Information provided by (Responsible Party):
Antonio Artigas Raventós, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01747057
First received: November 29, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Hemodynamics
 Behavioral: Dynamic-parameters-guided fluid management
Behavioral: Standard-guided-fluid management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monitoring Resuscitation in Severe Sepsis and Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Mortality at 28 days [ Time Frame: 28 days after hospital admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of resuscitation [ Time Frame: 72 hours after protocol inclusion ] [ Designated as safety issue: No ]
    • Vasopressor use and fluid load between 0h to 6h
    • Vasopressor use and fluid load between 7h to 72h

  • Ventilator-free days [ Time Frame: 28 days after admission ] [ Designated as safety issue: No ]
    From 1 to 28 days over 28 days in a month.

  • Vasopressor-free days [ Time Frame: 28 days after admission ] [ Designated as safety issue: No ]
    From 1 to 28 days over 28 days in a month.

  • Organ failure-free days [ Time Frame: 28 days after admission ] [ Designated as safety issue: No ]
    Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.

  • ICU length of stay [ Time Frame: At ICU discharge (expected average 30 days after admission) ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: At hospital discharge (expected average 45 days after hospital admission) ] [ Designated as safety issue: No ]
  • Renal function evolution [ Time Frame: 3 days after study enrollment ] [ Designated as safety issue: No ]
    Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).

  • Mortality at 3 months [ Time Frame: 3 months after admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 952
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynamic guide resuscitation
This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management.
 Behavioral: Dynamic-parameters-guided fluid management

● 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.
Active Comparator: Standard resuscitation
This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations.
 Behavioral: Standard-guided-fluid management
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
    • 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.
  • Prior hemodynamic monitoring by arterial catheter.
  • Central venous catheter.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747057

Contacts
Contact: Xaime Garcia, MD +34937231010 ext 21156 xgarcia@tauli.cat
Contact: Gisela Gili, RN +34937231010 ext 21159 ggilis@tauli.cat

Locations
Spain
Area de Critics. Hospital de Sabadell Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Gemma Goma, RN     937231010 ext 21179     ggoma@tauli.cat    
Principal Investigator: Xaime Garcia, MD            
Sub-Investigator: Guillem Gruartmoner, MD            
Sponsors and Collaborators
Corporacion Parc Tauli
  More Information

Additional Information:
Spanish webpage of the study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Antonio Artigas Raventós, Director of Critical Care Area, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01747057     History of Changes
Other Study ID Numbers: MORESS
Study First Received: November 29, 2012
Last Updated: December 10, 2012
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013