Goal-directed Hemodynamic Therapy in Patiens Undergoing Major Hepatic Resection

NCT04517409 | Completed DMC

• 1 other identifier: 4161
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Pre-defined postoperative complications for each patient were recorded after surgery from the patient record and by visiting patients on the ward by the investigators

  180 days

Study Arms (2)

GDHT

EXPERIMENTAL

After hepatic resection (Dynamic phase), the patients received an initial hemodynamic assessment based on PPV, CI and MAP. First, preload was optimized by fluid loading until PPV was \<14% or VVS \<12%, subjects were given 4 ml kg-1 boluses colloid solution every 5 minutes. At this point, the patient's individual preload optimized CI was determined and used as the hemodynamic goal until the end of surgery. Only if this value was below 2.5 L/min/(m2), inotropes were applied to reach this minimum CI, serving as a safety parameter to prevent patients from low cardiac output. If PPV and CI were within the target range but MAP was below 65 mmHg or PPV/VVS\>1,2, vasopressors were started. After the initial assessment, patients were reassessed every 15 minutes intraoperatively to maintain values.

Procedure: Goal-directed hemodynamic therapy

Control

OTHER

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

Procedure: Control

Interventions

Goal-directed hemodynamic therapy PROCEDURE

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

Also known as: GDHT

GDHT

Control PROCEDURE

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.

Control

Eligibility Criteria

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

You may qualify if:

• All patients scheduled for hepatic resection of more than two segments

You may not qualify if:

• age less than 18, body weight less than 50 kg or more than 150 kg, irregular heart rhythm, severe cardiovascular disease (chronic heart failure, valvular abnormality, cardiomyopathy, etc.), severe liver dysfunction (Child Pugh score B or C).

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized trial

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: November 5, 2015
• Primary Completion: November 5, 2017
• Study Completion: November 5, 2017
• Last Updated: August 18, 2020

Record last verified: 2020-08