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

Large Bowel Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320891
• Other study ID #: HC-I-H-0909
• Status: Completed
• Phase: N/A
• First received: March 8, 2011
• Last updated: May 3, 2017
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: May 2017
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Large Bowel Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	S.Anna Universitary Hospital	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara	B. Braun Melsungen AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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