Fluid Optimisation in Laparoscopic Colorectal Procedures

January 18, 2021 updated by: Alenka Spindler-Vesel, University Medical Centre Ljubljana
Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our study compared two groups of patients undergoing elective laparoscopic colorectal surgery: a control group (CG) in which standard haemodynamic monitoring was used, and a study group (SG) in which extended haemodynamic monitoring was applied with appropriate intraoperative interventions. Differences in intraoperative fluid management, hospital stay, and postoperative morbidity were observed.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients, undergoing elective laparoscopic colorectal surgery

Exclusion Criteria:

  • Patients with cardiac arrhythmias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Standard perioperative anesthesia management
Active Comparator: Study group
Perioperative extended haemodynamic monitoring of fluid loading, cardiac output and changes of peripheral vascular resistance by analysing the arterial curve was provided by non-invasive haemodynamic monitoring (LIDCO Rapid, Lidco Ltd., United Kingdom).In SG fluid optimisation was performed before pneumoperitoneum and after abdominal desuflation with actions to achieved CI, MAP and SI within 80% of baseline values.
Procedure: Perioperative fluid optimisation

In case of stroke volume variation (SVV) >10% and SI and CI >10% below the starting value, fluid challenge was performed with approximately 2 ml/kg of colloid over maximum of 5 minutes. The response was monitored.

If there was a fall in SVV and an increase in SI of >10% and the SVV still >10%, the second fluid challenge was performed.

If there was still a reduction in SVV after the second fluid challenge, but an increase in nSI <10% and decrease in systemic vascular resistance (SVR), no additional fluids were given. Vasoactive drugs were used instead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalisation
Time Frame: 1 month after admission
1 month after admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Perioperative complications
Time Frame: 8 days after surgery
8 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Alenka Spindler Vesel, asoc Prof, Department of anesthesiology and surgical intensive care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 18, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 127/5/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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