Acute Kidney InjuryPhase 4NCT01920126
The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
A Phase 4 study testing sodium bicarbonate and Saline in people with Acute Kidney Injury, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- sodium bicarbonate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2013to 23 Aug 2016
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis
Who cannot join
- end stage renal disease (serum creatinine concentration > 300 μmol/L)
- on dialysis
- chronic moderate to high dose corticosteroid therapy (> 10 mg/day prednisolon or equivalent)
- preoperative severe hypernatremia (Na+ > 150 mmol/L), alkalemia (PH > 7.50), or pulmonary edema
- neurocognitive dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.
- Conditions
- Acute Kidney Injury
- Being tested
- sodium bicarbonate, Saline
- Keywords
- sodium bicarbonate, renal function, infective endocarditis, open heart surgery
- Medical subject headings
- Acute Kidney Injury, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate group | Experimental | Sodium bicarbonate group Receives: Drug: sodium bicarbonate |
| Saline group | Placebo comparator | Saline group Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
We would investigate if the peak creatinine level during the postoperative 48h would differ by more than 0.3 mg/dL between two groups. The primary outcome was decided based on the AKIN criteria which defines acute kidney injury if serum creatinine increases more than 0.3 mg/dL during the postoperative 48 h.
; increase in serum creatinine of 0.3 mg/dL or >50 percent developing over <48 hours
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study start13 Aug 2013
- Primary completion23 Aug 2016
- Study completion23 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920126
- Sponsor's protocol ID
- 4-2013-0376
- Status last verified
- Jul 2018
- First submitted
- 31 Jul 2013
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho JS, Soh S, Shim JK, Kang S, Choi H, Kwak YL. Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo-controlled trial. Crit Care. 2017 Jan 5;21(1):3. doi: 10.1186/s13054-016-1591-z.
PubMed 28057030
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT01920126
- Acronym / sponsor ID
- 4-2013-0376
- Conditions
- Acute Kidney Injury
- Keywords
- sodium bicarbonate, renal function, infective endocarditis, open heart surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 23 Aug 2016 (actual)
- Study completion
- 23 Aug 2016 (actual)
- First posted
- 9 Aug 2013 (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 study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate group | Experimental | Drug: sodium bicarbonateSodium bicarbonate group |
| Saline group | Placebo comparator | Drug: SalineSaline group |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis
Key exclusion criteria (5 listed)
- end stage renal disease (serum creatinine concentration > 300 μmol/L)
- on dialysis
- chronic moderate to high dose corticosteroid therapy (> 10 mg/day prednisolon or equivalent)
- preoperative severe hypernatremia (Na+ > 150 mmol/L), alkalemia (PH > 7.50), or pulmonary edema
- neurocognitive dysfunction
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 |
|---|---|---|
| sodium bicarbonate0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery | Drug | Sodium bicarbonate group |
| Saline | Drug | Saline group |
Primary outcome
Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
Time frame: postoperative 48 hours
We would investigate if the peak creatinine level during the postoperative 48h would differ by more than 0.3 mg/dL between two groups. The primary outcome was decided based on the AKIN criteria which defines acute kidney injury if serum creatinine increases more than 0.3 mg/dL during the postoperative 48 h. ; increase in serum creatinine of 0.3 mg/dL or >50 percent developing over <48 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 17 Jul 2018.
- Derived from this study: PubMed 28057030Cho JS, Soh S, Shim JK, Kang S, Choi H, Kwak YL. Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo-controlled trial. Crit Care. 2017 Jan 5;21(1):3. doi: 10.1186/s13054-016-1591-z.
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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 Phase 4 study testing sodium bicarbonate and Saline in people with Acute Kidney Injury, run by Yonsei University at 1 site in South Korea.
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 5 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 17 Jul 2018. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups. (time frame: postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920126, which also lists 1 linked publication.
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 17 Jul 2018.