Intra Operative Fluid ManagementNCT01722630
Renal Function During Laparoscopic Surgery
A study testing Dopamine in people with Intra Operative Fluid Management, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 24 to 42 years, women only
- Conditions the study is for
- Intra Operative Fluid Management
- What is being tested?
- Dopamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Oct 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 24 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I
- age 24-42
- patients undergoing gynaecological laparoscopy
Who cannot join
- cardiovascular diseases
- renal and endocrine disorders
- obesity (BMI > 30 Kg/m2)
- the assumption of drugs that could interfere with renal parameters considered in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery
Aim of this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.
- Conditions
- Intra Operative Fluid Management
- Being tested
- Dopamine
- Keywords
- dopamine, laparoscopy, fluid management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopamineDrug
Also called Revivan
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Patients received intravenously saline solution at 5 ml/Kg/h |
| dopamine | Experimental | Patients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min Receives: Drug: Dopamine |
| crystalloids | No intervention | Patients received intravenously saline solution at 10 ml/Kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated glomerular filtration rate, tissue Doppler imaging, E/Ea
EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.
Measured: patients will be followed for the duration of surgery, an expected average of 3 hours
Secondary outcomes (1)
total intra operative diuresis (TID)
TID will be measured at the end of surgery
Measured: patients will be followed for the duration of surgery, an expected average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Operative Fluid ManagementStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Bevilacqua, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722630
- Sponsor's protocol ID
- FRF-2012-DH
- Status last verified
- Nov 2012
- First submitted
- 2 Nov 2012
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Infusion and Crystalloids Administration Improve Renal Function During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01722630
- Acronym / sponsor ID
- FRF-2012-DH
- Conditions
- Intra Operative Fluid Management
- Keywords
- dopamine, laparoscopy, fluid management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Nov 2012 (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 this study was to investigate the cardiac and renal responses to the administration of different amount of crystalloids, with and without dopamine, during gynaecological laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Patients received intravenously saline solution at 5 ml/Kg/h |
| dopamine | Experimental | Drug: DopaminePatients received intravenously saline solution at 5 ml/Kg/h and dopamine at 3 mcg/Kg/min |
| crystalloids | No intervention | –Patients received intravenously saline solution at 10 ml/Kg/h |
Who may qualify
- Ages
- 24 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I
- age 24-42
- patients undergoing gynaecological laparoscopy
Key exclusion criteria (4 listed)
- cardiovascular diseases
- renal and endocrine disorders
- obesity (BMI > 30 Kg/m2)
- the assumption of drugs that could interfere with renal parameters considered in the study
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 |
|---|---|---|
| DopamineAlso: Revivan | Drug | dopamine |
Primary outcome
estimated glomerular filtration rate, tissue Doppler imaging, E/Ea
Time frame: patients will be followed for the duration of surgery, an expected average of 3 hours
EGFr, tissue Doppler imaging and E/Ea are registered after the induction of pneumoperitoneum and Trendelemburg position, and compared to those registered before the induction of anesthesia.
1 secondary outcome
total intra operative diuresis (TID)
Time frame: patients will be followed for the duration of surgery, an expected average of 3 hours
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 7 Nov 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dopamine in people with Intra Operative Fluid Management, run by Catholic University of the Sacred Heart 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 3 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 7 Nov 2012. 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?
estimated glomerular filtration rate, tissue Doppler imaging, E/Ea (time frame: patients will be followed for the duration of surgery, an expected average of 3 hours). 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 7 Nov 2012.