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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Università degli Studi di Ferrara.
Recruitment status was Recruiting

Sponsor:

Collaborator:

B. Braun Melsungen AG

Information provided by:

Università degli Studi di Ferrara

ClinicalTrials.gov Identifier:

NCT01320891

First received: March 8, 2011

Last updated: March 22, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2011

Last Updated Date

March 22, 2011

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

acid/base disorder [ 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 ] [ Designated as safety issue: Yes ]

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01320891 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

pro/antiinflammatory cytokine [ 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 ] [ Designated as safety issue: Yes ]

-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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma of the Large Intestine

Intervention ^ICMJE

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 Name: sterofundin, tetraspan
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 Name: Normal saline, Amidolite

Study Arm (s)

Experimental: balanced
arm in which the subjects received only balanced solutions

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

Intervention: Behavioral: not balanced

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carlo A Volta, Professor	0532237005 ext 0039	vlc@unife.it
Contact: Lucia Farabegoli, MD	0532237007 ext 0039	farabegolilucia@gmail.com

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01320891

Other Study ID Numbers ^ICMJE

HC-I-H-0909

Has Data Monitoring Committee

Yes

Responsible Party

Prof. Carlo Alberto Volta, Ferrara University

Study Sponsor ^ICMJE

Università degli Studi di Ferrara

Collaborators ^ICMJE

B. Braun Melsungen AG

Investigators ^ICMJE

Study Chair:

Carlo A Volta, Professor

Ferrara Univesity

Information Provided By

Università degli Studi di Ferrara

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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