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

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 Overview

• Status: Completed
• Conditions: Large Bowel Cancer
• Intervention / Treatment: Behavioral: balanced solutions; Behavioral: not balanced

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44100
    • S.Anna Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: B. Braun Melsungen AG
• Investigators: Study Chair: Carlo A Volta, Professor, Ferrara Univesity

Publications and helpful links

General Publications

• Volta CA, Trentini A, Farabegoli L, Manfrinato MC, Alvisi V, Dallocchio F, Marangoni E, Alvisi R, Bellini T. Effects of two different strategies of fluid administration on inflammatory mediators, plasma electrolytes and acid/base disorders in patients undergoing major abdominal surgery: a randomized double blind study. J Inflamm (Lond). 2013 Sep 24;10(1):29. doi: 10.1186/1476-9255-10-29.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: general anaesthesia for major abdominal surgery
• Other Study ID Numbers: HC-I-H-0909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No