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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320891

Enrollment

Registered

2011-03-23

Start date

2010-02-28

Completion date

2012-02-29

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large Bowel Cancer

Keywords

general anaesthesia for major abdominal surgery

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

Interventions

BEHAVIORALbalanced 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.

BEHAVIORALnot 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026