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Fluid Responsiveness After CArdiac Surgery Study

NCT02841943 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2017-03-21

No results posted yet for this study

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

Conditions

  • Critically Ill
  • Hypovolemia

Sponsors & Collaborators

  • South West Sydney Local Health District

    lead OTHER

Principal Investigators

  • Anders Aneman, MD, PhD · Liverpool Hospital, South Western Sydney Local Health District

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841943 on ClinicalTrials.gov