Large Bowel CancerNCT01320891
Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
A study testing balanced solutions and not balanced in people with Large Bowel Cancer, run by Università degli Studi di Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Large Bowel Cancer
- What is being tested?
- balanced solutions and not balanced
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of large bowel cancer
- Age > 18 years old
Who cannot join
- 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)
Show all 9Show fewer
- Preoperative anaemia ( Hb < 10 g/dl )
- Allergy to hydrossietilic starches
- Patient rejection to share the study
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Large Bowel Cancer
- Being tested
- balanced solutions, not balanced
- Keywords
- general anaesthesia for major abdominal surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanced solutionsBehavioural
Also called sterofundin, tetraspan
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 balancedBehavioural
Also called Normal saline, Amidolite
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 group | Role | What they receive |
|---|---|---|
| balanced | Experimental | arm in which the subjects received only balanced solutions Receives: Behavioral: balanced solutions |
| not balanced | Experimental | arm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline Receives: Behavioral: not balanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery
Secondary outcomes (1)
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)
Measured: T0: anaesthesia induction (control value) T1:end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Bowel CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Responsible party
- Principal investigator, Carlo Alberto Volta, Università degli Studi di Ferrara
- Investigators
- Carlo A Volta, Professor, Study chair, Ferrara Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320891
- Sponsor's protocol ID
- HC-I-H-0909
- Status last verified
- May 2017
- First submitted
- 8 Mar 2011
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24059479
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators
- ClinicalTrials.gov ID
- NCT01320891
- Acronym / sponsor ID
- HC-I-H-0909
- Conditions
- Large Bowel Cancer
- Keywords
- general anaesthesia for major abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Feb 2010 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balanced | Experimental | Behavioral: balanced solutionsarm in which the subjects received only balanced solutions |
| not balanced | Experimental | Behavioral: not balancedarm in which the subjects received only not balanced solutions that means only normal saline and colloid dissolved in normal saline |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of large bowel cancer
- Age > 18 years old
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balanced solutionsAlso: sterofundin, tetraspanduring 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. | Behavioural | balanced |
| not balancedAlso: Normal saline, Amidoliteduring 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. | Behavioural | not balanced |
Primary outcome
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
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 24059479Volta 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.
Related trials for Large Bowel Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo A Volta, Professor study chair
Ferrara Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balanced solutions and not balanced in people with Large Bowel Cancer, run by Università degli Studi di Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.