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

N/ACompletedNCT01320891

Università degli Studi di Ferrara40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Large Bowel Cancer

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

S.Anna Universitary Hospital

Ferrara, Italy

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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