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

Not Applicable

Terminated

• Conditions: Emergency; Trauma; Surgery; Hypovolemic Shock
• Interventions: Other: CONTROL; Other: OPTIMIZED

• Registration Number: NCT01653977
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adults > 18 years
• Severe hypovolemic condition°
• Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min.

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
• Ultra-emergent surgery with no further diagnostic investigation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	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	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).

Primary Outcome Measures

Name	Time	Method
Delta 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.	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).

Secondary Outcome Measures

Name	Time	Method
Cardiovascular complications: myocardial infarct or congestive heart failure	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Cerebral complications: stroke	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Pulmonary complications: ALI/ARDS, bronchopneumonia	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Pulmonary complications: respiratory insufficiency necessitating re-intubation	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Surgical complications: re-operation for bleeding or infection	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Total duration of ventilation : days	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Renal complications: infection, urosepsis or renal insufficiency	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
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.
Duration of post-operative mechanical ventilation: in hours	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.	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.
Death	Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
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.
Mortality	From randomization up to 28 days
SOFA score measurement	From randomization : day 1, day 2, day 3
Number of unexpected ICU admission	From randomization up to 28 days

Trial Locations

Locations (1)

Hôpitaux universitaires de Genève; 🇨🇭 Genève, Switzerland