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

Università degli Studi di Ferrara

Status: Completed

Conditions: Large Bowel Cancer

Treatments: Behavioral: not balanced; Behavioral: balanced solutions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01320891

HC-I-H-0909

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

balanced

Experimental group

Description:

arm in which the subjects received only balanced solutions

Treatment:

Behavioral: balanced solutions

not balanced

Experimental group

Description:

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

Treatment:

Behavioral: not balanced