Monitoring Resuscitation in Severe Sepsis and Septic Shock

Hemodynamics Clinical Trial

Official title:

Monitoring Resuscitation in Severe Sepsis and Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01747057
• Other study ID #: MORESS
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2012
• Last updated: February 12, 2014
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: February 2014
• Source: Corporacion Parc Tauli
• Contact: Xaime Garcia, MD
• Phone: +34937231010
• Email: xgarcia[@]tauli.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 952
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamics

Intervention

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. PPV >12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ [(PPmax+PPmin)/2] x100 (during 5 respiratory cycles) 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-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.

Locations

Country	Name	City	State
Spain	Area de Critics. Hospital de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 28 days		28 days after hospital admission	No
Secondary	Length of resuscitation	Vasopressor use and fluid load between 0h to 6h; Vasopressor use and fluid load between 7h to 72h	72 hours after protocol inclusion	No
Secondary	Ventilator-free days	From 1 to 28 days over 28 days in a month.	28 days after admission	No
Secondary	Vasopressor-free days	From 1 to 28 days over 28 days in a month.	28 days after admission	No
Secondary	Organ failure-free days	Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.	28 days after admission	No
Secondary	ICU length of stay		At ICU discharge (expected average 30 days after admission)	No
Secondary	Hospital length of stay		At hospital discharge (expected average 45 days after hospital admission)	No
Secondary	Renal function evolution	Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).	3 days after study enrollment	No
Secondary	Mortality at 3 months		3 months after admission	No

External Links

•   Spanish webpage of the study