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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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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RECRUITING PHASE4

Detailed Description

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Conditions

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Large Bowel Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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balanced

arm in which the subjects received only balanced solutions

Group Type EXPERIMENTAL

balanced solutions

Intervention Type BEHAVIORAL

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.

not balanced

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

Group Type EXPERIMENTAL

not balanced

Intervention Type BEHAVIORAL

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.

Interventions

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balanced 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.

Intervention Type BEHAVIORAL

not 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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sterofundin, tetraspan Normal saline, Amidolite

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No