DiuresisNCT00550186
Effect of Preload on Bladder Retention Volume During Spinal Anesthesia
A study testing Ringers Lactate and HaemoHES 6% in people with Diuresis and Bladder Retention Volume, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess the influence of different fluid infusions on the quantity of bladder retention after spinal anesthesia. This study should determine if this increase in bladder retention is significant and relevant. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Diuresis, Bladder Retention Volume, Hypotension
- What is being tested?
- Ringers Lactate and HaemoHES 6%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Dec 2007
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA1-2
- undergoing minor procedure under spinal anesthesia
Who cannot join
- ASA3-4
- History or signs of heart failure / coronary artery disease.
- Bladder / urinary disease
- Neurologic disease that may affect bladder function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravascular Preload on Bladder Retention Volume During Spinal Anesthesia Induced Detrusor Blockade
The purpose of this study is to assess the influence of different fluid infusions on the quantity of bladder retention after spinal anesthesia. This study should determine if this increase in bladder retention is significant and relevant.
Read the detailed description
Background of the study:
Spinal anesthesia , through interruption of spinal nerve conduction, causes intense blockade of sensation, motor function as well as (para)sympathetic function. Loss of sympathetic tone causes vasodilation which may lead to arterial hypotension and bradycardia. To avoid these effects, in anesthetic practice, usually intravenouspreload is administered as cristalloids or colloids. The form and dosage of these plasma expanders will influence diuresis during spinal anesthesia-induced detrusor blockade. Excess diuresis may cause bladder distension and neccecitates bladder catheterization
Objective of the study:
To compare the quantitative effects of Ringer Lactate and HES 6% on diuresis during spinal anesthesia-induced detrusor blockade as well as prevention of hypotension and vasopressor use.
Study design:
Before spinal anesthesia is performed, patients are randomized into one of the 3 study groups (no preload, preload with Ringers' Lactate 14 ml/kg, preload with HES 6% 7 ml/kg). Spinal anesthesia is administerd with lidocaine 2% 70mg. Hypotension is treated with vasopressors, atropine or additional intravenous fluid. Bladder scans will be performed on the recovery unit and day-case unit. Total urinary volume is measured until sensory function at dermatome S2/3 is restored and spontanous voiding is possible.
Study population:
ASA 1-2 patients who present for spinal anesthesia for minor surgery on the lower extremitiy. Age 18-60 years.
Intervention (if applicable):
Prespinal administration of intravenous Ringers' Lactate 14 ml/kg or HES 6% 7 ml/kg.
Primary study parameters/outcome of the study:
Primary outcome is total urinary volume during spinal induced detrusor blockade, and number of subjects that have a bladdder volume over 500ml.
Secundary study parameters/outcome of the study (if applicable):
Secondary outcome parameters:
Periods of hypertension, and total dose of vasopressor en extra fluid administration.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Except for extra bladderscan and block height measurements, all actions are part of routine anesthesiologic care.
Ga naar boven
- Conditions
- Diuresis, Bladder Retention Volume, Hypotension
- Being tested
- placebo, Ringers Lactate, HaemoHES 6%
- Keywords
- spinal anesthesia, preload, diuresis, bladder retention
- Medical subject headings
- Hypotension, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Ringers LactateDrug
HaemoHES 6%Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | No preload Receives: Other: placebo |
| 2 | Active comparator | Preload with cristalloid infusion Receives: Drug: Ringers Lactate |
| 3 | Active comparator | Preload with collid infusion Receives: Drug: HaemoHES 6% |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiuresisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marco Peters, MD, Principal investigator, Nijmegen University Anesthesiology Department (resident)Ed Kamphuis, Md, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550186
- Sponsor's protocol ID
- LTC-420-071206
- Status last verified
- Jun 2016
- First submitted
- 26 Oct 2007
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravascular Preload on Bladder Retention Volume During Spinal Anesthesia Induced Detrusor Blockade
- ClinicalTrials.gov ID
- NCT00550186
- Acronym / sponsor ID
- LTC-420-071206
- Conditions
- Diuresis, Bladder Retention Volume, Hypotension
- Keywords
- spinal anesthesia, preload, diuresis, bladder retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- First posted
- 29 Oct 2007 (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 assess the influence of different fluid infusions on the quantity of bladder retention after spinal anesthesia. This study should determine if this increase in bladder retention is significant and relevant.
Detailed description
Background of the study:
Spinal anesthesia , through interruption of spinal nerve conduction, causes intense blockade of sensation, motor function as well as (para)sympathetic function. Loss of sympathetic tone causes vasodilation which may lead to arterial hypotension and bradycardia. To avoid these effects, in anesthetic practice, usually intravenouspreload is administered as cristalloids or colloids. The form and dosage of these plasma expanders will influence diuresis during spinal anesthesia-induced detrusor blockade. Excess diuresis may cause bladder distension and neccecitates bladder catheterization
Objective of the study:
To compare the quantitative effects of Ringer Lactate and HES 6% on diuresis during spinal anesthesia-induced detrusor blockade as well as prevention of hypotension and vasopressor use.
Study design:
Before spinal anesthesia is performed, patients are randomized into one of the 3 study groups (no preload, preload with Ringers' Lactate 14 ml/kg, preload with HES 6% 7 ml/kg). Spinal anesthesia is administerd with lidocaine 2% 70mg. Hypotension is treated with vasopressors, atropine or additional intravenous fluid. Bladder scans will be performed on the recovery unit and day-case unit. Total urinary volume is measured until sensory function at dermatome S2/3 is restored and spontanous voiding is possible.
Study population:
ASA 1-2 patients who present for spinal anesthesia for minor surgery on the lower extremitiy. Age 18-60 years.
Intervention (if applicable):
Prespinal administration of intravenous Ringers' Lactate 14 ml/kg or HES 6% 7 ml/kg.
Primary study parameters/outcome of the study:
Primary outcome is total urinary volume during spinal induced detrusor blockade, and number of subjects that have a bladdder volume over 500ml.
Secundary study parameters/outcome of the study (if applicable):
Secondary outcome parameters:
Periods of hypertension, and total dose of vasopressor en extra fluid administration.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Except for extra bladderscan and block height measurements, all actions are part of routine anesthesiologic care.
Ga naar boven
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: placeboNo preload |
| 2 | Active comparator | Drug: Ringers LactatePreload with cristalloid infusion |
| 3 | Active comparator | Drug: HaemoHES 6%Preload with collid infusion |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA1-2
- undergoing minor procedure under spinal anesthesia
Key exclusion criteria (4 listed)
- ASA3-4
- History or signs of heart failure / coronary artery disease.
- Bladder / urinary disease
- Neurologic disease that may affect bladder function
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 |
|---|---|---|
| placebo | Other | 1 |
| Ringers Lactate | Drug | 2 |
| HaemoHES 6% | Drug | 3 |
Primary outcome
Not reported in the source record.
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 28 Jun 2016.
Related trials for Diuresis
Recruiting
Natriuresis-guided Depletion After Cardiac Surgery
Cardiac Surgery, Diuresis
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.
Marco Peters, MD principal investigator
Nijmegen University Anesthesiology Department (resident)
Ed Kamphuis, Md, PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringers Lactate and HaemoHES 6% in people with Diuresis and Bladder Retention Volume, run by Rijnstate Hospital at 1 site in Netherlands.
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 4 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 28 Jun 2016. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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.
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 28 Jun 2016; AzTrials last refreshed its copy on 6 Nov 2026.