Fluid Responsiveness After CArdiac Surgery Study

NCT02841943 | Completed

• 1 other identifier: LIVICU001
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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. 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. 2.to assess correlations between central and peripheral variables (outlined below) relevant to oxygen delivery/consumption
3. 3.to assess correlations between a set of variables (outline below) and patient centred outcomes in ICU and in hospital
4. 4.Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)
5. 5.Common carotid arterial Doppler
6. 6.Arterial/mixed venous/central venous blood gas analyses
7. 7.Haemodynamic parameters
8. 8.Organ support measures
9. 9.ICU admission (within 30 minutes)
10. 10.Before administration of a fluid bolus
11. 11.After administration of a fluid bolus
12. 12.6 hours after ICU admission
13. 13.Morning of first postoperative day (12-24 hours)
14. 14.the response to intravascular volume expansion
15. 15.ICU mortality, morbidity and length of stay and hospital mortality and length of stay
16. 16.Clinical data are collected bedside using an electronic case record form
17. 17.Descriptive statistics
18. 18.Paired and unpaired comparative
19. 19.Correlative and predictive statistics

Conditions

Critically Ill; Hypovolemia

Keywords

Fluid responsiveness; Near-infrared spectroscopy; Thoracic surgery; Hypovolemia; veno-arterial carbon dioxide gradient; arterio-venous oxygen gradient; hypercarbia; Carotid artery; ultrasonography; Doppler

Outcome Measures

Primary Outcomes (2)

• Fluid bolus responsiveness

  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

  Approximately 30 minutes

• Volume management responsiveness

  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

  Approximately 6 hours

Secondary Outcomes (2)

• Morbidity

  At ICU discharge, an average of 4 days

• Mortality

  Up to 3 months

Eligibility Criteria

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

Study Population

All adult patients electively admitted to the Intensive Care Unit following cardiac surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• South West Sydney Local Health District: lead

Study Sites (1)

Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District

Liverpool, New South Wales, 1871, Australia

Location

Related Publications (3)

• Gupta K, Sondergaard S, Parkin G, Leaning M, Aneman A. Applying mean systemic filling pressure to assess the response to fluid boluses in cardiac post-surgical patients. Intensive Care Med. 2015 Feb;41(2):265-72. doi: 10.1007/s00134-014-3611-2. Epub 2015 Jan 8.

  PMID: 25567379 BACKGROUND

• Sondergaard S, Parkin G, Aneman A. Central venous pressure: soon an outcome-associated matter. Curr Opin Anaesthesiol. 2016 Apr;29(2):179-85. doi: 10.1097/ACO.0000000000000305.

  PMID: 26825283 BACKGROUND

• Rangappa R, Sondergaard S, Aneman A. Improved consistency in interpretation and management of cardiovascular variables by intensive care staff using a computerised decision-support system. Crit Care Resusc. 2014 Mar;16(1):48-53.

  PMID: 24588436 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Hypovolemia; Hypercapnia

Condition Hierarchy (Ancestors)

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

Study Officials

• Anders Aneman, MD, PhD

  Liverpool Hospital, South Western Sydney Local Health District

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Specialist

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 22, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)