NCT01320891

Brief Summary

Aim of the study is to ascertain whether a different strategy of fluids administration can be responsible of differences in terms of acid/base disorders (Stewart approach), pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated either with not-balanced solutions (Normal Saline) or balanced solutions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

March 8, 2011

Last Update Submit

May 3, 2017

Conditions

Large Bowel Cancer

Keywords

general anaesthesia for major abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • acid/base disorder

    the investigators assess difference in acid base disorders between the two groups measuring emogas analyses data and blood electrolites levels at the same time (two days)

    T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery

Secondary Outcomes (1)

  • pro/antiinflammatory cytokine

    T0: anaesthesia induction (control value) T1:end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery

Study Arms (2)

balanced

EXPERIMENTAL

arm in which the subjects received only balanced solutions

Behavioral: balanced solutions

not balanced

EXPERIMENTAL

arm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline

Behavioral: not balanced

Interventions

balanced solutionsBEHAVIORAL

during the general anaesthesia until 8 o'clock of the day after the operation the subject will receive only balanced fluids that means balanced crystalloid and colloids dissolved in balanced solution. 12 ml /Kg/h during operation time. ratio 3:1 between crystalloid and colloid.

Also known as: sterofundin, tetraspan
balanced
not balancedBEHAVIORAL

during the operation time until the 8 o'clock of the day after the operation, the subjects will receive only normal saline and colloid dissolved in normal saline.

Also known as: Normal saline, Amidolite
not balanced

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of large bowel cancer
  • Age \> 18 years old

You may not qualify if:

  • Emergency surgery for bowel punch or intestinal occlusion
  • Massive bleeding
  • Therapy with corticosteroid or nonsteroid antiinflammatory substances
  • Renal insufficiency (serum creatinine \> 200 micromol /l)
  • Cardiac insufficiency (NYHA III-IV)
  • Altered liver function (ALT \> 40 U/l AST \>40 U/l)
  • Preoperative anaemia ( Hb \< 10 g/dl )
  • Allergy to hydrossietilic starches
  • Patient rejection to share the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.Anna Universitary Hospital

Ferrara, 44100, Italy

Location

Related Publications (1)

  • Volta CA, Trentini A, Farabegoli L, Manfrinato MC, Alvisi V, Dallocchio F, Marangoni E, Alvisi R, Bellini T. Effects of two different strategies of fluid administration on inflammatory mediators, plasma electrolytes and acid/base disorders in patients undergoing major abdominal surgery: a randomized double blind study. J Inflamm (Lond). 2013 Sep 24;10(1):29. doi: 10.1186/1476-9255-10-29.

    PMID: 24059479DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

sterofundinSaline Solution

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Carlo A Volta, Professor

    Ferrara Univesity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 23, 2011

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

IT(1)