Fluid Optimisation in Laparoscopic Colorectal Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-09-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Perioperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Standard perioperative anesthesia management

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Perioperative fluid optimisation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE