An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients

Cardiac Surgery Clinical Trial

Official title:

A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681758
• Other study ID #: AICU2012-007
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2012
• Last updated: July 9, 2013
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery

Description:

1. The investigators will study patients after cardiac surgery

2. The investigators will collect data on standard care in pre-intervention population

3. The investigators will collect demographic and clinical data

4. The investigators will collect biochemical data in the first 24 hours after surgery

5. The investigators will collect biochemical, physiological and clinical outcome data

6. The investigators will compare the standard care and intervention period data

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. immediately after ICU admission after cardiac surgery

2. mandatory mechanical ventilation -

Exclusion Criteria:

1. Pressure support ventilation

2. ECMO

3. Intra-aortic balloon counterpulsation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• IV fluid according to PPV
intravenous fluids
• fluids according to standard care

Locations

Country	Name	City	State
Australia	Austin Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiological outcome	cardiac index	24 hours	Yes
Primary	Mean amount of fluid given in the first 24 hours after surgery	all intravenous fluid administered	24 hours	Yes
Secondary	Physiological outcome	Blood lactate	24 hours	Yes