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Goal-directed Hemodynamic Therapy in Patiens Undergoing Major Hepatic Resection

NCT04517409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-08-18

No results posted yet for this study

Summary

The aim of the study of patients undergoing major hepatic resection was compared standard perioperative (control Group) with hemodinamic management based on PPV, VVS, continuos CO trending and dynamic arterial elastance using radial artery pulse contour analysis (GDHT group). We hypothessized that following this treatment regimen after hepatic resection results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secundary endpoint)

Conditions

  • Hemodynamic Monitoring

Interventions

PROCEDURE

Goal-directed hemodynamic therapy

Eligible patients were equally randomized into two study groups: 1) Standard perioperative (Control group ) and 2) hemodinamic management based using radial artery pulse contour analysis (GDHT group). Randomization was performed the day before surgery by the study member responsable for anesthesia delivery using sealed opaque envelope technique stored in non-transparent containers with group allocation in a 1:1 ratio. Only patients were blinded to group allocation. Care providers and investigators could not be blinded due to the presence of the cardiac index trending monitor

PROCEDURE

Control

Before hepatic resection (Static phase) all patiens received continuous infusion of balanced crystalloid with the goal of CVP of 5 mmHg. After hepatic resection (Dynamic phase), the patiens received colloid solution, vasopressors, and inotropes at the discretion of the anaesthetist, acording to CVP, MAP and orine output. In this group, CO monitoring was not performed. Intraoperative treatment goals in the control arm were flexible to avoid both extremes of clinical practice and practice misalignment.

Sponsors & Collaborators

  • Castilla-La Mancha Health Service

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-05
Primary Completion
2017-11-05
Completion
2017-11-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517409 on ClinicalTrials.gov