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OpenTrials
Completed

NCT Number: NCT04719884

Fluid Optimisation in Laparoscopic Colorectal Procedures

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.

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Key information

Conditions

Perioperative Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients, undergoing elective laparoscopic colorectal surgery

Exclusion criteria

  • Patients with cardiac arrhythmias

Treatment and study plan

Perioperative fluid optimisation

Procedure

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.

Primary outcomes

  1. Duration of hospitalisation

    Time frame: 1 month after admission

Secondary outcomes

  1. Perioperative complications

    Time frame: 8 days after surgery

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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