Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fluid Responsiveness After CArdiac Surgery Study (FRACAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841943
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Anders Aneman, South West Sydney Local Health District

Brief Summary:

Study Design: Prospective observational study

Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health District, Sydney, Australia.

Target study size: 100 patients

Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital (LPOOL) as a Low Negligible Risk (LNR) project [HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47, HREC/LNR/14/LPOOL/150]

Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between March-October 2016

Aims:

  1. to determine the descriptive and predictive value of variables (outlined below) related to oxygen delivery/consumption in regards to the effects of intravascular volume expansion
  2. to assess correlations between central and peripheral variables (outlined below) relevant to oxygen delivery/consumption
  3. to assess correlations between a set of variables (outline below) and patient centred outcomes in ICU and in hospital

Main variables collected:

  1. Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)
  2. Common carotid arterial Doppler
  3. Arterial/mixed venous/central venous blood gas analyses
  4. Haemodynamic parameters
  5. Organ support measures

Data collection time points:

  1. ICU admission (within 30 minutes)
  2. Before administration of a fluid bolus
  3. After administration of a fluid bolus
  4. 6 hours after ICU admission
  5. Morning of first postoperative day (12-24 hours)

Outcome measures:

  1. the response to intravascular volume expansion
  2. ICU mortality, morbidity and length of stay and hospital mortality and length of stay

Data analysis:

  1. Clinical data are collected bedside using an electronic case record form
  2. Descriptive statistics
  3. Paired and unpaired comparative
  4. Correlative and predictive statistics

Condition or disease
Critically Ill Hypovolemia

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fluid Responsiveness After Cardiac Surgery (FRACAS) Study
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016



Primary Outcome Measures :
  1. Fluid bolus responsiveness [ Time Frame: Approximately 30 minutes ]
    Fluid responsiveness will be determined by any increase in cardiac output (continuous outcome) or by a 10-15% increase in cardiac output (dichotomous outcome) following bolus volume expansion

  2. Volume management responsiveness [ Time Frame: Approximately 6 hours ]
    Responders will be defined as patients with an improvement (change towards normal physiological values) following cumulative volume expansion in any variable(s) used to assess oxygen delivery/consumption balance


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: At ICU discharge, an average of 4 days ]
    Use and extent of measures to support organ function such as mechanical ventilation, mechanical and pharmacological cardiovascular interventions, renal replacement therapy whilst admitted to ICU as well as length of admission to ICU.

  2. Mortality [ Time Frame: Up to 3 months ]
    Vital status censored at discharge from ICU and hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients electively admitted to the Intensive Care Unit following cardiac surgery
Criteria

Inclusion Criteria:

  • Admitted following elective cardiac surgery
  • Adult (>18 years of age)
  • Pulmonary artery, central venous and arterial catheters inserted

Exclusion Criteria:

  • Emergency Patients (surgery immediately or within 12 hours of admission to hospital)
  • Children (< 18 years of age)
  • Patients admitted to ICU with ongoing extracorporeal circulatory support
  • Patients re-admitted to ICU within same index hospital admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841943


Locations
Layout table for location information
Australia, New South Wales
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
Liverpool, New South Wales, Australia, 1871
Sponsors and Collaborators
South West Sydney Local Health District
Investigators
Layout table for investigator information
Study Director: Anders Aneman, MD, PhD Liverpool Hospital, South Western Sydney Local Health District
Publications:
Layout table for additonal information
Responsible Party: Anders Aneman, Senior Staff Specialist, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02841943    
Other Study ID Numbers: LIVICU001
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anders Aneman, South West Sydney Local Health District:
Fluid responsiveness
Near-infrared spectroscopy
Thoracic surgery
Hypovolemia
veno-arterial carbon dioxide gradient
arterio-venous oxygen gradient
hypercarbia
Carotid artery
ultrasonography
Doppler
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Hypovolemia
Disease Attributes
Pathologic Processes