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

Not Applicable

Completed

• Conditions: Large Bowel Cancer
• Interventions: Behavioral: balanced solutions; Behavioral: not balanced

• Registration Number: NCT01320891
• Lead Sponsor: Università degli Studi di Ferrara

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2011-08
• Study Completion: 2012-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
acid/base disorder	T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery	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)

Secondary Outcome Measures

Name	Time	Method
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	-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)

Trial Locations

Locations (1)

S.Anna Universitary Hospital; 🇮🇹 Ferrara, Italy