Fluid BalanceNCT02219607
Liver Enzymes and Fluid Balance Following Colorectal Surgery
An observational study of Fluid Balance, run by Attikon Hospital at 1 site in Greece.
Trial summary
The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery. Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fluid Balance
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2014to Mar 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing colorectal surgery
Who may be able to join
- Patients undergoing colorectal surgery
Who cannot join
- Severe cardiac failure Severe renal failure Severe liver failure
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Attikon Hospital
Chaïdári, 12462
Georgia Kostopanagiotou, MD, PhD, 00302105832372
Epistimi Sachitzi, MD
About this study
The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery.
Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.
- Conditions
- Fluid Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| epidural | Not described | |
| general anesthesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver enzymes
Measured: 5 days postoperatively
Secondary outcomes (1)
Change in BNP (brain natriuretic peptide)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid BalanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pandazi Ageliki, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219607
- Sponsor's protocol ID
- colorectal 1
- Status last verified
- Aug 2014
- First submitted
- 16 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Enzymes and Fluid Balance Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02219607
- Acronym / sponsor ID
- colorectal 1
- Conditions
- Fluid Balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 19 Aug 2014 (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.
The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery.
Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural | – | – |
| general anesthesia | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing colorectal surgery
Key inclusion criteria (1 listed)
- Patients undergoing colorectal surgery
Key exclusion criteria (1 listed)
- Severe cardiac failure Severe renal failure Severe liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in liver enzymes
Time frame: 5 days postoperatively
1 secondary outcome
Change in BNP (brain natriuretic peptide)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
Related trials for Fluid Balance
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
Not yet recruitingPhase 2
Nutrition and Swelling
Postoperative Recovery, Total Knee Arthroplasty
Recruiting
Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury
Fluid Balance
Not yet recruiting
Digital Flashcards for Fluid and Electrolyte Education in Surgical Nursing: A Solomon Four-Group Study
Education, Surgical Nursing
Recruiting
Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy
AKI - Acute Kidney Injury, Fluid Balance
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Balance, run by Attikon Hospital at 1 site in Greece.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Aug 2014. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ageliki Pandazi, MD,PhD (00302105832374, angpant@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver enzymes (time frame: 5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2014.