Kidney Failure, AcutePhase 2NCT00484354
Use of Bicarbonate to Reduce the Incidence of Acute Renal Failure After Cardiac Surgery
A Phase 2 study testing Sodium bicarbonate, Normal saline and Bicarbonate in people with Kidney Failure, Acute and Renal Replacement Therapy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Acute, Renal Replacement Therapy
- What is being tested?
- Sodium bicarbonate, Normal saline and Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2013
- 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
- Calculated GFR ≤ 60 ml/min/m2 (MDRD)
- OR
- Any combination of two (2) of the following:
- Age ≥ 70
- Complex surgery (any of the following):
- CABG/Valve
Show all 13Show fewer
- Redo operation
- Deep hypothermic arrest
- ≥ 2 valves
- History of PVD surgery
- EF < 35%
- Presence of diabetes mellitus
- Prior kidney transplant
Who cannot join
- Age < 18
- Pre-existing ESRD (dialysis patients)
- Pre-op GFR ≤ 15 ml/min/m2
- Pre-op bicarbonate level ≥ 30 mEq/L
- Emergency surgery (unable to effectively consent)
- Pregnancy
- Heart transplant (OHT)
- Aortic surgery (proximal or distal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline
The purpose of this study is to determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.
Read the detailed description
This is a randomized, controlled, single center study in patients felt to be at high risk for ARF following CABG surgery. Patients who have met the selection criteria noted below will be randomized to one of two treatment arms:
- Patients allocated to the sodium bicarbonate (NaHCO3) arm will receive a 0.150 M NaHCO3 solution prepared in a sterile water base. An initial bolus of 0.150 M NaHCO3 at 5.0 ml/kg will be given over fifteen minutes prior to surgery. Following the bolus, the 0.150 M NaHCO3 infusion will be run at 1.0 ml/kg/hr during the procedure and for six (6) hours afterwards. The NaHCO3 infusion will then be decreased to 0.4 ml/kg/hr for a further twelve (12) hours. The goal in the NaHCO3 arm is to provide a total dose of approximately 2.5-3.0 mEq/kg of sodium bicarbonate. This dose was determined from prior studies and found to lead to a slight increase in the serum bicarbonate level post-operatively. Anecdotally, the metabolic stress of CABG surgery often leads to a decline in the serum bicarbonate level in patients not treated with alkali therapy.
II) Patients allocated to the normal saline (NS) arm will receive an initial bolus consisting of 0.154 M NaCl (NS) at 5.0 ml/kg given over fifteen minutes prior to surgery. Following the bolus, these patients will receive NS (0.154 M) at a rate of 1.0 ml/kg/hour during the procedure and for six (6) hours afterwards. The rate will then be decreased to 0.4 ml/kg/hour for a further twelve (12) hours as done in the NaHCO3 treatment arm above. There will be a maximum rate of infusion of 125 mL/min used in both study arms to avoid volume overload issues in morbidly obese patients.
There will be no other deviation from standard protocol when treating these patients undergoing CABG at our institution. The standard protocol is dictated by both the cardiothoracic surgeons and anesthesiologists involved with each individual case. The purpose of this study is to compare the incidence of ARF (maximal change in SCr) in high risk patients undergoing CABG when treated with either a NS or NaHCO3 maintenance infusion. This study will test the hypothesis that treatment with NaHCO3 may have a protective effect over NS in preventing AFR following CABG in a high risk population.
- Conditions
- Kidney Failure, Acute, Renal Replacement Therapy
- Being tested
- Sodium bicarbonate, Normal saline, Bicarbonate, Placebo
- Keywords
- Acute Renal Failure, Cardiac Surgery, Sodium Bicarbonate, Length of Stay, Mortality
- 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.
Sodium bicarbonateDrug
IV bicarbonate given with amount based on patient weight
Normal salineOther
IV Normal saline with volume given determined by patient weight
BicarbonateOther
IV bicarbonate, dosed by weight
PlaceboOther
Normal saline, with volume given based on patient weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bicarbonate administration Receives: Drug: Sodium bicarbonate; Other: Bicarbonate |
| 2 | Placebo comparator | Normal saline administration Receives: Other: Normal saline; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed Acute Kidney Injury Within 72 Hours
Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline
Measured: 72 hours post-operative
Secondary outcomes (4)
Change in GFR Over 72 Hours Post Operatively
25% or greater change in serum creatinine level
Measured: 72 hours
Length of Hospital Stay
Length of hospital stay in days
Measured: Until hospital discharge, up to 30 days
Number of Participants With Need for Dialysis
Number of participants needing dialysis
Measured: Until hospital discharge, up to 30 days
Mortality
Number of patients who died during the hospitalization
Measured: Until hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2011
- Study completionDec 2013
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.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael V. Rocco, MD, Principal investigator, Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484354
- Sponsor's protocol ID
- IRB00002409
- Status last verified
- Sep 2018
- First submitted
- 6 Jun 2007
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Acute Renal Failure Associated With Cardiovascular Surgery: A Randomized Study Comparing Sodium Bicarbonate to Normal Saline
- ClinicalTrials.gov ID
- NCT00484354
- Acronym / sponsor ID
- IRB00002409
- Conditions
- Kidney Failure, Acute, Renal Replacement Therapy
- Keywords
- Acute Renal Failure, Cardiac Surgery, Sodium Bicarbonate, Length of Stay, Mortality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Posted 16 Oct 2018
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 determine if the incidence of acute renal failure (ARF) in high risk patients who undergo coronary artery bypass grafting (CABG) is reduced by treating patients in the perioperative period with intravenous (IV) sodium bicarbonate. Patients will be randomized in a 50:50 allocation to receive either IV sodium bicarbonate or IV normal saline. The volume of fluid given in each arm of the study is equal. All other interventions in those patients will be according to standard cardiothoracic anesthesia protocol at our institution.
Detailed description
This is a randomized, controlled, single center study in patients felt to be at high risk for ARF following CABG surgery. Patients who have met the selection criteria noted below will be randomized to one of two treatment arms:
- Patients allocated to the sodium bicarbonate (NaHCO3) arm will receive a 0.150 M NaHCO3 solution prepared in a sterile water base. An initial bolus of 0.150 M NaHCO3 at 5.0 ml/kg will be given over fifteen minutes prior to surgery. Following the bolus, the 0.150 M NaHCO3 infusion will be run at 1.0 ml/kg/hr during the procedure and for six (6) hours afterwards. The NaHCO3 infusion will then be decreased to 0.4 ml/kg/hr for a further twelve (12) hours. The goal in the NaHCO3 arm is to provide a total dose of approximately 2.5-3.0 mEq/kg of sodium bicarbonate. This dose was determined from prior studies and found to lead to a slight increase in the serum bicarbonate level post-operatively. Anecdotally, the metabolic stress of CABG surgery often leads to a decline in the serum bicarbonate level in patients not treated with alkali therapy.
II) Patients allocated to the normal saline (NS) arm will receive an initial bolus consisting of 0.154 M NaCl (NS) at 5.0 ml/kg given over fifteen minutes prior to surgery. Following the bolus, these patients will receive NS (0.154 M) at a rate of 1.0 ml/kg/hour during the procedure and for six (6) hours afterwards. The rate will then be decreased to 0.4 ml/kg/hour for a further twelve (12) hours as done in the NaHCO3 treatment arm above. There will be a maximum rate of infusion of 125 mL/min used in both study arms to avoid volume overload issues in morbidly obese patients.
There will be no other deviation from standard protocol when treating these patients undergoing CABG at our institution. The standard protocol is dictated by both the cardiothoracic surgeons and anesthesiologists involved with each individual case. The purpose of this study is to compare the incidence of ARF (maximal change in SCr) in high risk patients undergoing CABG when treated with either a NS or NaHCO3 maintenance infusion. This study will test the hypothesis that treatment with NaHCO3 may have a protective effect over NS in preventing AFR following CABG in a high risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sodium bicarbonate, Other: BicarbonateBicarbonate administration |
| 2 | Placebo comparator | Other: Normal saline, Other: PlaceboNormal saline administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Calculated GFR ≤ 60 ml/min/m2 (MDRD)
- OR
- Any combination of two (2) of the following:
- Age ≥ 70
- Complex surgery (any of the following):
Key exclusion criteria (8 listed)
- Age < 18
- Pre-existing ESRD (dialysis patients)
- Pre-op GFR ≤ 15 ml/min/m2
- Pre-op bicarbonate level ≥ 30 mEq/L
- Emergency surgery (unable to effectively consent)
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 bicarbonateIV bicarbonate given with amount based on patient weight | Drug | 1 |
| Normal salineIV Normal saline with volume given determined by patient weight | Other | 2 |
| BicarbonateIV bicarbonate, dosed by weight | Other | 1 |
| PlaceboNormal saline, with volume given based on patient weight | Other | 2 |
Primary outcome
Number of Participants Who Developed Acute Kidney Injury Within 72 Hours
Time frame: 72 hours post-operative
Number (percentage) of patients who developed acute kidney injury within 72 hours, defined by an increase in serum creatinine level of 0.3 mg/dl from baseline
4 secondary outcomes
Change in GFR Over 72 Hours Post Operatively
Time frame: 72 hours
Length of Hospital Stay
Time frame: Until hospital discharge, up to 30 days
Number of Participants With Need for Dialysis
Time frame: Until hospital discharge, up to 30 days
Mortality
Time frame: Until hospital discharge, up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael V. Rocco, MD principal investigator
Wake Forest University School of Medicine, Dept of Internal Medicine, Division of Nephrology
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, Normal saline and Bicarbonate in people with Kidney Failure, Acute and Renal Replacement Therapy, run by Wake Forest University Health Sciences 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 13 inclusion and 8 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 16 Oct 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 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 16 Oct 2018). 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 Who Developed Acute Kidney Injury Within 72 Hours (time frame: 72 hours post-operative). 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 16 Oct 2018.