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

NCT01653977 | Terminated DMC

• 1 other identifier: NAC 09-044
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovolemic Shock; Trauma; Emergency; Surgery

Keywords

Hypovolemic shock; trauma; emergency; surgery; GDT; Picco

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (14)

• 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.

• Cerebral complications: stroke

  Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, 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.

• 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.

• 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.

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

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.

Other: CONTROL

OPTIMIZED

ACTIVE COMPARATOR

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).

Other: OPTIMIZED

Interventions

CONTROL 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.

Also known as: Standard care, trauma, fluide balance, Vasopressors

CONTROL

OPTIMIZED OTHER

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).

Also known as: Goal-directed therapy, Picco, Fluide balance optimized, Vasopressor, CI

OPTIMIZED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Shock; Wounds and Injuries; Emergencies

Interventions

Standard of Care; Vasoconstrictor Agents; point 4 composite resin; Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Critical Care; Patient Care; Therapeutics

Study Officials

• Gordana Pavlovic, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 31, 2012
• Study Start: February 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

CH (1)