Fluid restriction compared to fluid optimisation with the oesophageal doppler in colorectal surgery: a randomized clinical trial of efficacy

Not Applicable

Completed

• Conditions: Colorectal surgery; Fluid therapy intraoperative; Perioperative morbidity; Haemodynamic state intraoperative; Anaesthesiology - Anaesthetics; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000717853
• Lead Sponsor: Dr Tuong Dien Phan

Brief Summary

1. Research question This study investigates whether monitoring the heart function with a cardiac monitor and giving fluid to improve the amount the heart pumps is of benefit to a patient having a bowel surgery. 2. Background information Increasing the amount of blood flow may reduce complications such as infection and kidney dysfunction in patients having major bowel surgery. 3. Participant characteristics The patients are adults having abdominal surgery with bowel resection. 4. Key results In a study of 100 patients, there was no improvement in how long the patients stayed in hospital or the number of patients suffering complications with this technique of increasing blood flow using a cardiac output monitor. 5. Limitations This study may not have detected a smaller benefit that may be revealed in a larger group of patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-05
• Study Completion: 2014-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Elective major colorectal surgery
>18yrs of age
Enrollment into the Enhance Recovery After Surgery clinical care pathway.

Exclusion Criteria

Emergency surgery
Significant renal impairment
Hepatic dysfunction
Oesophageal pathology that is a contraindication to a oesophageal doppler probe
Inability to give informed consent
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication rate: number of complications during hospital stay.<br>We will use a standardised classfication and severity grading scale, based on the work of Dindo and Clavien.<br>This has a 17 point classification of complications (eg. Venous thromboembolism, sepsis, AMI). The severity grading scale is a 7 point scale (from I - deviation from normal postoperative course without the need for intervention to V-death). Further details can be found at http://www.surgicalcomplication.info[at hospital discharge];Length of Stay - defined by from date of admission to date of discharge. <br><br>[At hospital discharge]

Secondary Outcome Measures

Name	Time	Method
Change in Velocity Time Integral on Doppler examination across the Left Ventricular Outflow Tract.[At the beginning and end of surgery];Change in the stroke volume and cardiac output using intraoperative trans thoracic echocardiography.[At the beginning and end of surgery];Volume of fluid administration[Intraoperative];Vasopressor use[Intra-operative and until discharge from the recovery unit.]