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

Study Overview
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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

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

Conditions
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Large Bowel Cancer

Intervention / Treatment
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* Behavioral: balanced solutions
* Behavioral: not balanced


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balanced<br>arm in which the subjects received only balanced solutions | Behavioral: balanced solutions<br>* 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.<br>* Other names: sterofundin, tetraspan;|
| Experimental: not balanced<br>arm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline | Behavioral: not balanced<br>* 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.<br>* Other names: Normal saline, Amidolite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | T0: anaesthesia induction (control value) T1:end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anaesthesia for major abdominal surgery