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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01653977
Other study ID # NAC 09-044
Secondary ID
Status Terminated
Phase N/A
First received July 18, 2012
Last updated May 11, 2016
Start date February 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 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.


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 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

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


Related Conditions & MeSH terms


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 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).

Locations

Country Name City State
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
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