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

NCT ID: NCT01654003

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Severe Sepsis; Emergency; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary.

Group Type: ACTIVE_COMPARATOR

CONTROL

Intervention Type: OTHER

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 central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).

The administration of fluid (250-500ml crystalloids or colloids) and 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).

Group Type: ACTIVE_COMPARATOR

OPTIMIZED

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: OTHER

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).

Intervention Type: OTHER

Other Intervention Names

standard care; fluide therapy; vasopressor; sepsis; GDT fluide therapy; Picco

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Pavlovic Gordana, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Emergency operating room, Geneva Cantonal Hospital

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

NAC 09-044 B

Identifier Type: -

Identifier Source: org_study_id