Monitoring Resuscitation in Severe Sepsis and Septic Shock

NCT ID: NCT01747057

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 952 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-05-31

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.

Conditions

Hemodynamics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dynamic guide resuscitation

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

Group Type: EXPERIMENTAL

Dynamic-parameters-guided fluid management

Intervention Type: 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.

Standard resuscitation

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

Group Type: ACTIVE_COMPARATOR

Standard-guided-fluid management

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporacion Parc Tauli

OTHER

Sponsor Role: lead

Responsible Party

Antonio Artigas Raventós

Director of Critical Care Area

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Area de Critics. Hospital de Sabadell

Sabadell, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Xaime Garcia, MD

Role: CONTACT

xgarcia@tauli.cat

+34937231010 ext. 21156

Gisela Gili, RN

Role: CONTACT

ggilis@tauli.cat

+34937231010 ext. 21159

Facility Contacts

Gemma Goma, RN

Role: primary

ggoma@tauli.cat

937231010 ext. 21179

Related Links

http://www.edusepsis.org/proyectos_fic.php?id_pro=10

Spanish webpage of the study

Other Identifiers

MORESS

Identifier Type: -

Identifier Source: org_study_id