Kidney InjuryPhase 2NCT00921518
Prevention of Acute Kidney Injury in Cardiac Surgery Patients
A Phase 2 study testing Sodium Bicarbonate in people with Kidney Injury, run by Community Medical Center, Scranton, PA at 1 site in United States.
Trial summary
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury
- What is being tested?
- Sodium Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
- baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation
Who cannot join
- cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump)
- end-stage kidney disease requiring dialysis
- received an infusion of sodium bicarbonate on the same day as cardiac surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Medical Center
Scranton, Pennsylvania, 18510
About this study
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of developing post-operative AKI. The purpose of the current study is to determine if intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is effective at preventing post-operative AKI in patients with baseline kidney insufficiency and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.
Read the detailed description
This is a randomized, placebo-controlled, prospective, double-blinded. The study will take place at Community Medical Center in Scranton, Pennsylvania. The inclusion criteria are patients undergoing elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass and having a baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation. Patients will be excluded from the study if they have cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump), end-stage kidney disease requiring dialysis, received an infusion of sodium bicarbonate on the same day as cardiac surgery, or if they are enrolled in a separate clinical research trial. This trial will involve two treatment groups. Group one will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution using the same infusion regimen as described above for isotonic saline. The primary efficacy outcome of the study will be the incidence of AKI postoperatively. Acute kidney injury will be defined as an increase in serum creatinine concentration by at least 25% from baseline or an absolute increase of 0.5 mg/dL at any time within the first five postoperative days.
- Conditions
- Kidney Injury
- Being tested
- 0.9% Sodium Chloride (Placebo), Sodium Bicarbonate
- Keywords
- Cardiac surgery, Sodium bicarbonate, Acute kidney injury, Saline
- 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.
0.9% Sodium Chloride (Placebo)Drug
Also called Normal Saline
0.9% Sodium Chloride (placebo) will infuse at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
Sodium BicarbonateDrug
Also called Bicarbonate
Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. Receives: Drug: 0.9% Sodium Chloride (Placebo) |
| Sodium Bicarbonate | Active comparator | This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. Receives: Drug: Sodium Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Kidney Injury
Acuge kidney injury is defined using the AKIN criteria
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney InjuryStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Medical Center, Scranton, PA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith L. Kristeller, Community Medical Center, Scranton, PA
- Investigators
- Judith L Kristeller, PharmD, Principal investigator, Wilkes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921518
- Sponsor's protocol ID
- CMC AKICS
- Status last verified
- Mar 2014
- First submitted
- 15 Jun 2009
- Last updated
- 15 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kristeller JL, Zavorsky GS, Prior JE, Keating DA, Brady MA, Romaldini TA, Hickman TL, Stahl RF. Lack of effectiveness of sodium bicarbonate in preventing kidney injury in patients undergoing cardiac surgery: a randomized controlled trial. Pharmacotherapy. 2013 Jul;33(7):710-7. doi: 10.1002/phar.1262. Epub 2013 Apr 1.
PubMed 23553549
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Kidney Injury in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT00921518
- Acronym / sponsor ID
- CMC AKICS
- Conditions
- Kidney Injury
- Keywords
- Cardiac surgery, Sodium bicarbonate, Acute kidney injury, Saline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Community Medical Center, Scranton, PAUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Posted 11 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline. It occurs in 30% of patients following cardiac surgery, and at least 50% of patients with underlying renal insufficiency. Patients who have a reduced creatinine clearance pre-operatively are at the greatest risk of developing post-operative AKI. The purpose of the current study is to determine if intravenous hydration with either isotonic saline or sodium bicarbonate 150 mEq/L is effective at preventing post-operative AKI in patients with baseline kidney insufficiency and who are undergoing cardiac surgery using cardiopulmonary bypass. The study hypothesis is that an infusion of sodium bicarbonate 150 mEq/L will be more effective than isotonic saline in reducing the incidence of post-operative AKI in cardiac surgery patients with a preoperative glomerular filtration rate (GFR) less than 60 ml/min/1.73m2.
Detailed description
This is a randomized, placebo-controlled, prospective, double-blinded. The study will take place at Community Medical Center in Scranton, Pennsylvania. The inclusion criteria are patients undergoing elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass and having a baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation. Patients will be excluded from the study if they have cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump), end-stage kidney disease requiring dialysis, received an infusion of sodium bicarbonate on the same day as cardiac surgery, or if they are enrolled in a separate clinical research trial. This trial will involve two treatment groups. Group one will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution using the same infusion regimen as described above for isotonic saline. The primary efficacy outcome of the study will be the incidence of AKI postoperatively. Acute kidney injury will be defined as an increase in serum creatinine concentration by at least 25% from baseline or an absolute increase of 0.5 mg/dL at any time within the first five postoperative days.
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 |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: 0.9% Sodium Chloride (Placebo)This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. |
| Sodium Bicarbonate | Active comparator | Drug: Sodium BicarbonateThis arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective, urgent, or emergent cardiac surgery using cardiopulmonary bypass
- baseline GFR less than 60 ml/min/1.73m2 estimated using the Modification of Diet in Renal Disease equation
Key exclusion criteria (3 listed)
- cardiogenic shock (defined as a cardiac index less 2 L/min/m2 despite high dose inotropes or the need for intra-aortic balloon pump)
- end-stage kidney disease requiring dialysis
- received an infusion of sodium bicarbonate on the same day as cardiac surgery
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 |
|---|---|---|
| 0.9% Sodium Chloride (Placebo)Also: Normal Saline0.9% Sodium Chloride (placebo) will infuse at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. | Drug | Normal Saline |
| Sodium BicarbonateAlso: BicarbonateGroup two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass. | Drug | Sodium Bicarbonate |
Primary outcome
Number of Participants With Acute Kidney Injury
Time frame: 5 days
Acuge kidney injury is defined using the AKIN criteria
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23553549Kristeller JL, Zavorsky GS, Prior JE, Keating DA, Brady MA, Romaldini TA, Hickman TL, Stahl RF. Lack of effectiveness of sodium bicarbonate in preventing kidney injury in patients undergoing cardiac surgery: a randomized controlled trial. Pharmacotherapy. 2013 Jul;33(7):710-7. doi: 10.1002/phar.1262. Epub 2013 Apr 1.
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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.
Judith L Kristeller, PharmD principal investigator
Wilkes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Bicarbonate in people with Kidney Injury, run by Community Medical Center, Scranton, PA 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 3 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 15 Apr 2014. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Acute Kidney Injury (time frame: 5 days). 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 NCT00921518, 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 15 Apr 2014.