Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
Liverpool, New South Wales, 1871, Australia
NCT Number: NCT02841943
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
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Notify Me18 year and older
All sexes
Observational
Liverpool, New South Wales, 1871, Australia
This prospective observational study program has a set of objectives within three major domains that will be analysed separately and synergistically:
Peripheral near infra-red spectroscopy (NIRS)
Aims:
Hypotheses:
Main measurements:
Cardiac output and common carotid Doppler sonography
Aims:
Hypotheses:
Main measurements:
Oxygen and carbon dioxide gradients
Aims:
Hypotheses:
Main measurements
A fluid bolus will be administered as 250ml or 500ml of fluid (crystalloid or colloid) at 1500ml/hour. Measurements will be conducted immediately before fluid administration and 10 minutes post fluid cessation.
The following risk scores will be calculated: Sequential Organ Failure Assessment (SOFA), Acute Physiology and Chronic Health Evaluation (APACHE II and III), Simplified Acute Physiology Score (SAPS2), Australian New Zealand Risk of Death (ANZROD), Euroscore 2.
Routine biochemical tests will be recorded including electrolytes, renal function tests, liver function tests.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
Time frame: Up to 3 months
Vital status censored at discharge from ICU and hospital
South West Sydney Local Health District
Other
Fluid Responsiveness After Cardiac Surgery (FRACAS) Study
Acronym: FRACAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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