NCT02071524

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

3.5 years

First QC Date

January 28, 2014

Last Update Submit

November 7, 2016

Conditions

Mechanical Ventilation ComplicationActual Impaired Fluid Volume

Outcome Measures

Primary Outcomes (1)

  • effects on oxygenation, respiratory mechanics

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

    every 30 minutes till the end of surgery

Secondary Outcomes (1)

  • Incidence of respiratory complications

    28 days

Study Arms (2)

Cristalloid

ACTIVE COMPARATOR

group cristalloid (ringer lactate)

Drug: Cristalloid administration

colloids

ACTIVE COMPARATOR

colloid: cristalloid in according to cardiac output

Drug: Group Colloid

Interventions

Group ColloidDRUG

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

colloids
Cristalloid administrationDRUG

Only Ringer Lactate administration

Cristalloid

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ferrara

Ferrara, 44121, Italy

RECRUITING

Central Study Contacts

Savino Spadaro, researcher

CONTACT

+390532206570spdsvn@unife.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 28, 2014

First Posted

February 26, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

IT(1)