Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein

NCT ID: NCT01388998

Last Updated: 2012-04-24

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid management approach to avoid both hypervolemia and hypovolemia. However, several clinical factors may impede dPP measurements. Surgical manipulations in abdominal procedures may interfere with hemodynamic stability due to obstruction of the caval vein. Physiological considerations make us hypothesize that only intense pressure impedes caval blood flow and thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval vein.

Detailed Description

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Conditions

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Intravascular Volume Respiratory Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Interventions

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Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein

Following hepatic resection, a fitting area for pressure application on the caval vein will be identified by the attending surgeon. Baseline assessments of hemodynamic and heart-lung interaction parameters will be taken. Thereafter the surgeon will apply three different pressure levels (2 N, 5 N, 10 N) at random with a force gauge (Fa. ATP Messtechnik, Ettenheim, Germany). Assessment of the parameters will be performed after 2 minutes of pressure application by an investigator, unaware of the pressure applied. After each pressure application 5 minutes will be waited to assure hemodynamic recovery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line

Exclusion Criteria

* pregnancy
* cardiac insufficiency (NYHA 4, EF \< 25 %)
* coronary (CCS 4)
* coagulopathy
* symptoms of infection or sepsis
* malignant hyperthermia
* porphyria
* oesophageal varicose veins
* absence of sinus rhythm
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Lydia T. Strys

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lydia T. Strys, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Dorothea Closhen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Gunther Pestel, MD, PhD

Role: STUDY_DIRECTOR

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Locations

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Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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837.308.10(7317)

Identifier Type: -

Identifier Source: org_study_id

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