Fluid Optimisation in Laparoscopic Colorectal Procedures

NCT04719884 | Completed

• 1 other identifier: 127/5/12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perioperative Complication

Keywords

postoperative complications, intraoperative monitoring, haemodynamic monitoring, laparoscopic abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalisation

  1 month after admission

Secondary Outcomes (1)

• Perioperative complications

  8 days after surgery

Study Arms (2)

Control group

NO INTERVENTION

Standard perioperative anesthesia management

Study group

ACTIVE COMPARATOR

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

Interventions

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients, undergoing elective laparoscopic colorectal surgery

You may not qualify if:

• Patients with cardiac arrhythmias

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alenka Spindler Vesel, asoc Prof

  Department of anesthesiology and surgical intensive care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asist prof

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)