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Status unknownNCT02071524Updated Nov 8, 2016

Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics

An interventional study of Group Colloid and Cristalloid administration in Mechanical Ventilation Complication and Actual Impaired Fluid Volume, sponsored by Università degli Studi di Ferrara. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-08.

Sponsored by Università degli Studi di Ferrara · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The investigators hypothesize that large doses of fluids used during intraoperative could affect lung parenchyma structure and, consequently, gas exchange and respiratory mechanics. The purpose of this study is to evaluate fluids effects on oxygenation, respiratory mechanics, by using two different solutions: crystalloid or colloid.

Read the detailed description

Inclusion Criteria:

  • patients undergoing elective abdominal, thoracic, vascular surgery
  • minimum age 18 years
  • informed consent

Exclusion Criteria:

  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency

Respiratory mechanic parameters (i.e., inspiratory peak pressure, plateau pressure, total airway resistance, and static compliance) are obtained .Blood samples are drawn simultaneously from the arterial catheters for gas analysis. Data were collected after induction of anesthesia (T0) after 1 h (T1), 2 h (T2), 3 h (T3) and at the end of surgery.

Primary outcome: evaluate the fluids effects on oxygenation, respiratory mechanics

Secondary outcome: Incidence of surgery related complications

02

Conditions studied

  • Mechanical Ventilation Complication
  • Actual Impaired Fluid Volume
03

In context

Lead sponsor

Università degli Studi di Ferrara is the lead sponsor of 64 studies on the registry; 10 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing elective abdominal, thoracic, vascular surgery
  • minimum age 18 years
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • patients with severe cardiomyopathy or severe heart failure
  • history of coagulation disorders
  • patients with severe cardiovascular or respiratory disorders
  • renal insufficiency
  • severe liver diseases
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Cristalloid

    group cristalloid (ringer lactate)

    Drug: Cristalloid administration

  • Active comparator
    colloids

    colloid: cristalloid in according to cardiac output

    Drug: Group Colloid

Interventions

  • DrugGroup Colloid

    Group Colloid: cristalloid 1:2 (gelofusine: ringer lactate)

  • DrugCristalloid administration

    Only Ringer Lactate administration

06

What researchers measure

Primary outcomes

  1. effects on oxygenation, respiratory mechanics

    Lung compliance (l/cmH20), Airaway resistance (cmH2O/L/sec) and PaO2 will be measured

    Time frame: every 30 minutes till the end of surgery

Secondary outcomes

  1. Incidence of respiratory complications

    Complications like acute respiratory failure, pneumonia and ARDS will be recorded

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
  • University of Ferrara
    Ferrara, 44121, Italy
    • Carlo A Volta, professor · Contact · vlc@unife.it · +390532206570
    • Savino Spadaro, Researcher · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02071524
Lead sponsor
Università degli Studi di Ferrara
Responsible party
Savino Spadaro (Researcher, Università degli Studi di Ferrara) — Principal investigator
First posted
Feb 26, 2014
Start date
Sep 2013
Primary completion
Mar 2017 (estimated)
Completion
Apr 2017 (estimated)
Last update
Nov 8, 2016

Study contacts

Savino Spadaro, researcher
Contact
spdsvn@unife.it
+390532206570

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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