Monitoring Resuscitation in Severe Sepsis and Septic Shock
- Conditions
- Hemodynamics
- Interventions
- Behavioral: Dynamic-parameters-guided fluid managementBehavioral: Standard-guided-fluid management
- Registration Number
- NCT01747057
- Lead Sponsor
- Corporacion Parc Tauli
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 952
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dynamic guide resuscitation Dynamic-parameters-guided fluid management This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management. Standard resuscitation Standard-guided-fluid management This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations.
- Primary Outcome Measures
Name Time Method Mortality at 28 days 28 days after hospital admission
- Secondary Outcome Measures
Name Time Method Length of resuscitation 72 hours after protocol inclusion * Vasopressor use and fluid load between 0h to 6h
* Vasopressor use and fluid load between 7h to 72hVentilator-free days 28 days after admission From 1 to 28 days over 28 days in a month.
Vasopressor-free days 28 days after admission From 1 to 28 days over 28 days in a month.
Organ failure-free days 28 days after admission Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.
ICU length of stay At ICU discharge (expected average 30 days after admission) Hospital length of stay At hospital discharge (expected average 45 days after hospital admission) Renal function evolution 3 days after study enrollment Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).
Mortality at 3 months 3 months after admission
Trial Locations
- Locations (1)
Area de Critics. Hospital de Sabadell
🇪🇸Sabadell, Barcelona, Spain