ACTRN12616000538448
Completed
Phase 4
A Prospective Multicentre Randomized Controlled Trial of Standard Compared to Surgery Specific Goal-directed Therapy (GDT) for Patients Undergoing Pancreaticoduodenectomy
Austin Hospital0 sites52 target enrollmentApril 27, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Austin Hospital
- Enrollment
- 52
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients (age \> 18 years) undergoing pancreaticoduodenectomy
Exclusion Criteria
- •1\. Age less than 18 years
- •2\. Abnormal pre\-operative coagulopathy: INR (international normalised ratio) \> 1\.5, platelet count \< 75 x 109/l
- •3\. Severe hepatic insufficiency (bilirubin \> 30umol/L, ALP (alkaline phosphatase) \>300iu/L, ALT (alanine transaminase) \> 50iu/L, albumin \< 25g/dL, INR \> 1\.5\)
- •4\. Severe renal impairment: Serum Creatinine \>250ummol/L
- •5\. American Society of Anaesthesiologists (ASA) physical status IV or V
Outcomes
Primary Outcomes
Not specified
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