Acute Kidney FailurePhase 2/3PROMECNCT00472563
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
A Phase 2/3 study testing Bicarbinate 150 mEq/L in people with Acute Kidney Failure, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Bicarbinate 150 mEq/L
- How many people
- 212 participants
- Where
- 1 siteColombia
- Study dates
- May 2007to Feb 2008
- Phase
- Phase 2/3
- 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
- Adult, Older adult
Who may be able to join
- 18+ years of age
- Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either
- Serum creatinine 1.2 mg/dl or more, or
- Type 2 Diabetes Mellitus
Who cannot join
- Current clinical diagnosis of exacerbated congestive heart failure
- Exposure to contrast 30 days prior to study
- Allergy to contrast dye
- Chronic renal disease with dialysis therapy
- Acute renal failure with dialytic urgency
- Urgency procedure needed
Show all 11Show fewer
- Systolic blood pressure < 90 or vasopressor support
- No authorization by patient or physician in charge
- Serum potassium < 3 mEq/L
- Ejection fraction < 35% by previous echocardiography
- Acute pulmonary edema in previous 48 hours
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario San Vicente Paúl
Medellín, Antioquia, 57
About this study
Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
Read the detailed description
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.
Subjects: Consecutive samples of all inpatients who meet the inclusion criteria
Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast.
Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine.
Expected total enrollment: 212
Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others).
Condition: Contrast Induced Nephropathy
Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W
Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited
Facility location:
Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia.
- Conditions
- Acute Kidney Failure
- Being tested
- Bicarbinate 150 mEq/L
- Keywords
- bicarbonate, nephropathy, contrast
- Medical subject headings
- Acute Kidney Injury, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicarbinate 150 mEq/LDrug
75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W
What is being measured
The primary outcome is the main question the study is designed to answer.
development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
Measured: 48 h
Secondary outcomes (1)
change in serum bicarbonate; change in serum potassium; change in serum creatinine
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Investigators
- Wilmar A Maya Salazar, MD, Principal investigator, Universidad de AntioquiaJulián M Aristizábal, MD, Study chair, Universidad de AntioquiaOscar M Santos, MD, Study chair, Universidad de AntioquiaJohn F Nieto, MD, Study chair, Universidad de AntioquiaLiliana Jaramillo, MD, Study chair, Universidad de AntioquiaJorge I García, MD, Study chair, Universidad de AntioquiaFabian A Jaimes, MD, Study director, Universidad de AntioquiaAlvaro García, MD, Study chair, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472563
- Sponsor's protocol ID
- 065-120606
- Acronym
- PROMEC
- Status last verified
- Apr 2008
- First submitted
- 10 May 2007
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
- ClinicalTrials.gov ID
- NCT00472563
- Acronym / sponsor ID
- PROMEC / 065-120606
- Conditions
- Acute Kidney Failure
- Keywords
- bicarbonate, nephropathy, contrast
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 May 2007 (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.
Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
Detailed description
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.
Subjects: Consecutive samples of all inpatients who meet the inclusion criteria
Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast.
Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine.
Expected total enrollment: 212
Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others).
Condition: Contrast Induced Nephropathy
Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W
Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited
Facility location:
Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18+ years of age
- Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either
Key exclusion criteria (11 listed)
- Current clinical diagnosis of exacerbated congestive heart failure
- Exposure to contrast 30 days prior to study
- Allergy to contrast dye
- Chronic renal disease with dialysis therapy
- Acute renal failure with dialytic urgency
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 |
|---|---|---|
| Bicarbinate 150 mEq/L75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W | Drug | – |
Primary outcome
development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
Time frame: 48 h
1 secondary outcome
change in serum bicarbonate; change in serum potassium; change in serum creatinine
Time frame: 48 h
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 6 May 2008.
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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.
Wilmar A Maya Salazar, MD principal investigator
Universidad de Antioquia
Julián M Aristizábal, MD study chair
Universidad de Antioquia
Oscar M Santos, MD study chair
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bicarbinate 150 mEq/L in people with Acute Kidney Failure, run by Universidad de Antioquia at 1 site in Colombia.
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 4 inclusion and 11 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 6 May 2008. 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 Colombia. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast (time frame: 48 h). 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 6 May 2008.