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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Lydia T. Strys, Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT01388998

First received: July 5, 2011

Last updated: April 22, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2011

Last Updated Date

April 22, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change of dPP from start of intervention to 2 minutes after start of the intervention [ Time Frame: Application of pressure for 2 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01388998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

External Pressure Applied on the Caval Vein and Its Effects on Difference in Pulse Pressure (dPP) and Pleth Variability Index (PVI)

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Intravascular Volume
Respiratory Changes

Intervention ^ICMJE

Other: 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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01388998

Other Study ID Numbers ^ICMJE

837.308.10(7317)

Has Data Monitoring Committee

Responsible Party

Lydia T. Strys, Johannes Gutenberg University Mainz

Study Sponsor ^ICMJE

Johannes Gutenberg University Mainz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Lydia T. Strys, MD	Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Principal Investigator:	Dorothea Closhen, MD, PhD	Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Study Director:	Gunther Pestel, MD, PhD	Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Information Provided By

Johannes Gutenberg University Mainz

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top