Epidural AnesthesiaNCT00156338
Effect of Intraoperative Fluid Management on Morbidity
A study testing fluid management in people with Epidural Anesthesia, run by University Hospital Muenster at 3 sites in Germany.
Trial summary
The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epidural Anesthesia
- What is being tested?
- fluid management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2005to Dec 2010
- 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
- epidural anesthesia
- ASA I-III
Who cannot join
- metastasized cancer
- pregnancy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Raphaelsklinik
Münster, D-48143
St. Franziskus-Hospital Münster
Münster, D-48145
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, D-48149
About this study
Official title: Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery
The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity
- Conditions
- Epidural Anesthesia
- Being tested
- fluid management
- Keywords
- Fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid managementProcedure or surgery
volume and sodium restriction
fluid managementProcedure or surgery
volume restriction
fluid managementProcedure or surgery
liberal fluid management
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | volume and sodium restriction Receives: Procedure: fluid management |
| 2 | Active comparator | volume restriction Receives: Procedure: fluid management |
| 3 | Active comparator | liberal fluid management Receives: Procedure: fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause Morbidity
Measured: one year
Secondary outcomes (3)
Gastral and intestinal function
Measured: within the first 30 days after surgery
all cause Mortality
Measured: one year
Gastral and intestinal function
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Westphal, MD, Principal investigator, Department of Anesthesiology and Intensive Care, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156338
- Sponsor's protocol ID
- 02-Anast-05
- Status last verified
- Jan 2012
- First submitted
- 8 Sep 2005
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00156338
- Acronym / sponsor ID
- 02-Anast-05
- Conditions
- Epidural Anesthesia
- Keywords
- Fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Sep 2005 (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 purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: fluid managementvolume and sodium restriction |
| 2 | Active comparator | Procedure: fluid managementvolume restriction |
| 3 | Active comparator | Procedure: fluid managementliberal fluid management |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- epidural anesthesia
- ASA I-III
Key exclusion criteria (2 listed)
- metastasized cancer
- pregnancy
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 |
|---|---|---|
| fluid managementvolume and sodium restriction | Procedure or surgery | 1 |
| fluid managementvolume restriction | Procedure or surgery | 2 |
| fluid managementliberal fluid management | Procedure or surgery | 3 |
Primary outcome
all cause Morbidity
Time frame: one year
3 secondary outcomes
Gastral and intestinal function
Time frame: within the first 30 days after surgery
all cause Mortality
Time frame: one year
Gastral and intestinal function
Time frame: one year after 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 18 Jan 2012.
Related trials for Epidural Anesthesia
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
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.
Martin Westphal, MD principal investigator
Department of Anesthesiology and Intensive Care, University Hospital Münster
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluid management in people with Epidural Anesthesia, run by University Hospital Muenster at 3 sites in Germany.
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 2 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 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
all cause Morbidity (time frame: one year). 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 18 Jan 2012.