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CompletedNCT01388998Updated Apr 24, 2012

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

An interventional study of Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein in Intravascular Volume and Respiratory Changes, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-24.

Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intravascular Volume
  • Respiratory Changes

Keywords

  • fluid management
  • fluid therapy
  • dPP
  • difference in pulse pressure
  • PVI
  • pleth variability index
  • external pressure applied on the caval vein
03

In context

Lead sponsor

Johannes Gutenberg University Mainz is the lead sponsor of 156 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Interventions

  • OtherChanges 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.

06

What researchers measure

Primary outcomes

  1. Change of dPP from start of intervention to 2 minutes after start of the intervention

    Time frame: Application of pressure for 2 minutes

07

Study locations

1 site
  • Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
    Mainz, 55131, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Jan 2012 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 5, 2011
First posted
Jul 7, 2011
Start
Jan 2011
Primary completionActual
Jan 2012
CompletionActual
Jan 2012
Last update
Apr 24, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01388998
Responsible party
Lydia T. Strys (M.D., Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jul 7, 2011
Start date
Jan 2011
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Apr 24, 2012

Study contacts

Lydia T. Strys, MD
principal investigator · Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Dorothea Closhen, MD, PhD
principal investigator · Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Gunther Pestel, MD, PhD
study director · Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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