Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery

Surgery Clinical Trial

Official title:

Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01654003
• Other study ID #: NAC 09-044 B
• Status: Terminated
• Phase: N/A
• First received: July 18, 2012
• Last updated: May 11, 2016
• Start date: April 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Medic
• Study type: Interventional

Clinical Trial Summary

This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults > 18 years

• Severe sepsis* as defined by the ACCCP/SCCM consensus conference

• Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min (in and out patients).

Exclusion Criteria:

• Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC

• Neurotrauma (Glasgow Coma Score < 12) and/ or medullar trauma

• Known pregnancy or diagnosed by US or Ct-scan (> 14 weeks)

• Sustained cardiac arrhythmia (see Logbook P8)

• Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)

• Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)

• Burn injury > 10%

• Needed emergency thoracotomy or ABC resuscitation protocol

• Pre-existing severe liver dysfunction(Child-Pugh class C)

• Do-not-resuscitate order, died within 48h of admission

Study Design

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

Related Conditions & MeSH terms

• Emergencies
• Emergency
• Severe Sepsis
• Surgery

Intervention

Other:
• CONTROL
In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
• OPTIMIZED
In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).

Locations

Country	Name	City	State
Switzerland	Emergency operating room, Geneva Cantonal Hospital	Geneva
Switzerland	Hôpitaux Universitaires de Genève	Genève

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta lactate	The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (? lactate).	From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.	No
Secondary	Cardiovascular complications: myocardial infarct or congestive heart failure	Clinical outcome and surrogate biomarkers (Troponin-I and pro-BNP: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first	No
Secondary	Cerebral complications: stroke	Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Pulmonary complications: ALI/ARDS, bronchopneumonia	Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Pulmonary complications: respiratory insufficiency necessitating re-intubation	Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Surgical complications: re-operation for bleeding or infection	Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Renal complications: infection, urosepsis or renal insufficiency	Clinical outcome and surrogate biomarkers (Riffle score, creatinine: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first	No
Secondary	Duration of post-operative mechanical ventilation: in hours	Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Total duration of ventilation : days	Clinical outcomes (ventilation free days) will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first	No
Secondary	Length of stay in the ICU: in days		Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Length of stay in hospital: in days		Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	No
Secondary	Mortality		From randomization up to 28 days	No
Secondary	SOFA score measurement		From randomization : day 1, day 2, day 3	No
Secondary	Death		Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first	No
Secondary	Number of unexpected ICU admission		From randomization up to 28 days	No