Clinical trial NCT01747057: Monitoring Resuscitation in Severe Sepsis and Septic Shock
Official title: Monitoring Resuscitation in Severe Sepsis and Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodynamics
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 952
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mortality at 28 days
timeFrame: 28 days after hospital admission
Secondary outcomes:
measure: Length of resuscitation
timeFrame: 72 hours after protocol inclusion
measure: Ventilator-free days
timeFrame: 28 days after admission
measure: Vasopressor-free days
timeFrame: 28 days after admission
measure: Organ failure-free days
timeFrame: 28 days after admission
measure: ICU length of stay
timeFrame: At ICU discharge (expected average 30 days after admission)
measure: Hospital length of stay
timeFrame: At hospital discharge (expected average 45 days after hospital admission)
measure: Renal function evolution
timeFrame: 3 days after study enrollment
measure: Mortality at 3 months
timeFrame: 3 months after admission
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Area de Critics. Hospital de Sabadell
state: Barcelona
Study officials:
References: