Fluid BalanceNCT01168583
Fluid Balance and Clinical Outcomes
An observational study of Fluid Balance and Input and Output, run by University of Florida at 1 site in United States.
Trial summary
This study is about investigating the relationship of postoperative fluid balance, inflammation and acute kidney injury. This is a non-interventional study (no drug administration). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Balance, Input and Output, Inflammatory Mediators
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital for elective cardiothoracic surgery.
Who may be able to join
- Age 18 years or older, and
- Undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, and other cardiovascular surgery.
Who cannot join
- Pregnancy
- History of any organ transplant
- Preoperative intra-aortic balloon pump (IABP)
- Current use of natriuretic peptides
- ESRD patients on dialysis
- Estimated GFR < 30ml/min using MDRD equation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital, University of Florida
Gainesville, Florida, 32610
About this study
Official title: Investigation of the Effect of Post-operative Fluid Balance on Inflammatory Mediators in Patients Undergoing Cardiovascular Surgery
This study is about investigating the relationship of postoperative fluid balance, inflammation and acute kidney injury. This is a non-interventional study (no drug administration). The investigators will collect baseline demographic data, postoperative fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.
- Medical subject headings
- Acute Kidney Injury
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 |
|---|---|---|
| Positive Fluid Balance of 2000ml | Not described | |
| Negative Fluid Balance of 2000ml | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fluid BalanceStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A Ahsan Ejaz, M.D, Principal investigator, University of FloridaGanesh Kambhampati, M.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168583
- Sponsor's protocol ID
- 126-2010
- Status last verified
- Sep 2011
- First submitted
- 22 Jul 2010
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kambhampati G, Ejaz NI, Asmar A, Aiyer RK, Arif AA, Pourafshar N, Yalamanchili VR, Ejaz AA. Fluid balance and conventional and novel biomarkers of acute kidney injury in cardiovascular surgery. J Cardiovasc Surg (Torino). 2013 Oct;54(5):639-46.
PubMed 24002394Ejaz AA, Kambhampati G, Ejaz NI, Dass B, Lapsia V, Arif AA, Asmar A, Shimada M, Alsabbagh MM, Aiyer R, Johnson RJ. Post-operative serum uric acid and acute kidney injury. J Nephrol. 2012 Jul-Aug;25(4):497-505. doi: 10.5301/jn.5000173.
PubMed 22684655Kambhampati G, Ross EA, Alsabbagh MM, Asmar A, Pakkivenkata U, Ejaz NI, Arif AA, Ejaz AA. Perioperative fluid balance and acute kidney injury. Clin Exp Nephrol. 2012 Oct;16(5):730-8. doi: 10.1007/s10157-012-0623-5. Epub 2012 Mar 29.
PubMed 22457087
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Post-operative Fluid Balance on Inflammatory Mediators in Patients Undergoing Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT01168583
- Acronym / sponsor ID
- 126-2010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jul 2010 (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.
This study is about investigating the relationship of postoperative fluid balance, inflammation and acute kidney injury. This is a non-interventional study (no drug administration). The investigators will collect baseline demographic data, postoperative fluid balance status by Intake-output data, follow routine labs and collect 1 blood sample (0.5ml) with morning lab draws on day 1 and 5ml urine samples on day 1 and 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Fluid Balance of 2000ml | – | – |
| Negative Fluid Balance of 2000ml | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital for elective cardiothoracic surgery.
Key inclusion criteria (2 listed)
- Age 18 years or older, and
- Undergoing elective cardiothoracic surgery(s), alone or in combination with other procedures/surgery(s): thoracic aortic aneurysm, cardiac valves, coronary artery bypass grafting, abdominal thoracic aneurysm, and other cardiovascular surgery.
Key exclusion criteria (6 listed)
- Pregnancy
- History of any organ transplant
- Preoperative intra-aortic balloon pump (IABP)
- Current use of natriuretic peptides
- ESRD patients on dialysis
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
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 21 Sep 2011.
- Derived from this study: PubMed 24002394Kambhampati G, Ejaz NI, Asmar A, Aiyer RK, Arif AA, Pourafshar N, Yalamanchili VR, Ejaz AA. Fluid balance and conventional and novel biomarkers of acute kidney injury in cardiovascular surgery. J Cardiovasc Surg (Torino). 2013 Oct;54(5):639-46.
- Derived from this study: PubMed 22684655Ejaz AA, Kambhampati G, Ejaz NI, Dass B, Lapsia V, Arif AA, Asmar A, Shimada M, Alsabbagh MM, Aiyer R, Johnson RJ. Post-operative serum uric acid and acute kidney injury. J Nephrol. 2012 Jul-Aug;25(4):497-505. doi: 10.5301/jn.5000173.
- Derived from this study: PubMed 22457087Kambhampati G, Ross EA, Alsabbagh MM, Asmar A, Pakkivenkata U, Ejaz NI, Arif AA, Ejaz AA. Perioperative fluid balance and acute kidney injury. Clin Exp Nephrol. 2012 Oct;16(5):730-8. doi: 10.1007/s10157-012-0623-5. Epub 2012 Mar 29.
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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.
A Ahsan Ejaz, M.D principal investigator
University of Florida
Ganesh Kambhampati, M.D principal investigator
University of Florida
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 and Input and Output, run by University of Florida at 1 site in United States.
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 6 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 21 Sep 2011. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01168583, which also lists 3 linked publications.
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 21 Sep 2011.