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CompletedNCT01320891Updated May 8, 2017

Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators

An interventional study of balanced solutions and not balanced in Large Bowel Cancer, sponsored by Università degli Studi di Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-05-08.

Sponsored by Università degli Studi di Ferrara · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2010, registered Mar 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study 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

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Conditions studied

  • Large Bowel Cancer

Keywords

  • general anaesthesia for major abdominal surgery
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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.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    balanced

    arm in which the subjects received only balanced solutions

    Behavioral: balanced solutions

  • Experimental
    not balanced

    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

  • Behavioralbalanced solutions

    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

  • Behavioralnot balanced

    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

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What researchers measure

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)

    Time frame: 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

    -MMP-9 total and active, TIMP-1, IL-6, IL-8, IL-10, mieloperossidasis, ROS, MCP-3 will be measured during the observation period. (two days)

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

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Study locations

1 site
  • S.Anna Universitary Hospital
    Ferrara, 44100, Italy
08

References and documents

Publications

  • 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. PubMed 24059479 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01320891
Lead sponsor
Università degli Studi di Ferrara
Collaborators
B. Braun Melsungen AG
Responsible party
Carlo Alberto Volta (Professor, Università degli Studi di Ferrara) — Principal investigator
First posted
Mar 23, 2011
Start date
Feb 2010
Primary completion
Aug 2011
Completion
Feb 2012
Last update
May 8, 2017

Study contacts

Carlo A Volta, Professor
study chair · Ferrara Univesity

Oversight

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

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