Monitoring Resuscitation in Severe Sepsis and Septic Shock

Corporacion Parc Tauli

Status: Unknown

Conditions: Hemodynamics

Treatments: Behavioral: Dynamic-parameters-guided fluid management; Behavioral: Standard-guided-fluid management

Study type: Interventional

Funder types: Other

Identifiers

NCT01747057

MORESS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 952 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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952 participants in 2 patient groups

Dynamic guide resuscitation

Experimental group

Description:

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

Treatment:

Behavioral: Dynamic-parameters-guided fluid management

Standard resuscitation

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard-guided-fluid management