Kidney Failure, AcutePhase 4NCT00384995
Bicarbonate v Saline to Prevent Contrast Nephropathy
A Phase 4 study testing 0.9% (154 mEq/L) IV Sodium Chloride and 1/6 M (166 mEq/L) IV Sodium Bicarbonate in people with Kidney Failure, Acute and Contrast Media, run by Italian Society of Nephrology at 5 sites in Italy.
Trial summary
Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Acute, Contrast Media
- What is being tested?
- 0.9% (154 mEq/L) IV Sodium Chloride and 1/6 M (166 mEq/L) IV Sodium Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesItaly
- Study dates
- Dec 2006to Jul 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Booked for cardiac or other non-renal arteriography
- Pre-existing reduced kidney function: Serum Creatinine >= 1.3 \& <= 4 mg/dl (female gender) or >= 1.5 \& <= 5 mg/dl (male gender)
- Age > 18 years
Who cannot join
- GFR MDRD estimate < 15 ml/min/m2
- End-stage renal disease already on dialysis
- Known current Acute Kidney Failure with serum creatinine rise of > 0.5 mg/dl within 24 hours
- Pulmonary edema - current or within 48 hours
- Clinically relevant ascites, edema or other fluid overload
- Uncontrolled hypertension (> 165 mmHg systolic, or > 105 mmHg diastolic)
Show all 14Show fewer
- Hemodynamically unstable patient requiring IV nitroglycerine, or IV fluid or inotropes for blood pressure support
- Emergency (unplanned) angiography
- IV contrast procedure
- Exposure to iodinated radiocontrast within 3 days prior to study
- Prior anaphylactoid reaction to contrast
- Planned administration of N-acetylcysteine
- Planned administration of dopamine, fenoldopam or mannitol
- Current pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Spedali Civili di Brescia
Brescia, 25100
Ospedale Ferrarotto
Catania, 95100
P.O. Uboldo
Cernusco sul Naviglio, 20063
Azienda Istituti Ospitalieri di Cremona
Cremona, 26100
IRCCS Policlinico San Donato
San Donato, 20097
About this study
Official title: Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)
Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.
Read the detailed description
A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.
It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.
Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.
- Conditions
- Kidney Failure, Acute, Contrast Media
- Being tested
- 0.9% (154 mEq/L) IV Sodium Chloride, 1/6 M (166 mEq/L) IV Sodium Bicarbonate
- Keywords
- Contrast Induced Nephropathy, Chronic Kidney Disease, Acute Renal Failure, End-stage Renal Disease, Cardiovascular diseases, Coronary catheterization, Percutaneous coronary intervention, Intra-arterial angiography, Bicarbonate, Saline
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% (154 mEq/L) IV Sodium ChlorideDrug
Also called Sodium Chloride
Saline solution
1/6 M (166 mEq/L) IV Sodium BicarbonateDrug
Also called Sodium Bicarbonate
Bicarbonate solution
| Study group | Role | What they receive |
|---|---|---|
| Bicarbonate | Experimental | Bicarbonate solution infusion Receives: Drug: 1/6 M (166 mEq/L) IV Sodium Bicarbonate |
| Saline | Active comparator | Standard volume expansion Receives: Drug: 0.9% (154 mEq/L) IV Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast.
Measured: 48-72 hours
Secondary outcomes (6)
Group mean change in serum creatinine
Measured: 48-72 hours
Days in hospital within the week post contrast
Measured: One week
Requirement for dialysis
Measured: Two months
Atheroembolic events
Measured: Two months
Major adverse cardiovascular events
Measured: Two months
Death
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, AcuteStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Society of Nephrology
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Memorial University of Newfoundland
- Investigators
- Pietro Ravani, MD, MSc, Principal investigator, Italian Society of NephrologyBrendan BJ Barrett, MD, MSc, Study chair, Memorial University of NewfoundlandFerruccio Conte, MD, Study chair, Italian Society of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384995
- Sponsor's protocol ID
- PR021676
- Status last verified
- Nov 2010
- First submitted
- 5 Oct 2006
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
PubMed 15150204Ravani P, Tripepi G, Pecchini P, Mallamaci F, Malberti F, Zoccali C. Urotensin II is an inverse predictor of death and fatal cardiovascular events in chronic kidney disease. Kidney Int. 2008 Jan;73(1):95-101. doi: 10.1038/sj.ki.5002565. Epub 2007 Oct 17.
PubMed 17943084
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Bicarbonate Versus Saline Infusion Therapy to Prevent Contrast Induced Nephropathy (CAN-IT PREVENT Protocol)
- ClinicalTrials.gov ID
- NCT00384995
- Acronym / sponsor ID
- PR021676
- Conditions
- Kidney Failure, Acute, Contrast Media
- Keywords
- Contrast Induced Nephropathy, Chronic Kidney Disease, Acute Renal Failure, End-stage Renal Disease, Cardiovascular diseases, Coronary catheterization, Percutaneous coronary intervention, Intra-arterial angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Italian Society of NephrologyUniversity, hospital or other
- Collaborators
- European Commission, Memorial University of Newfoundland
- Study start
- Dec 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Oct 2006 (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.
Slowing of kidney function occurs in a minority of people given dye during angiography. The purpose of this study is to compare two different types of fluid given into a vein to reduce the risk of kidney injury: salt in water or baking soda in water.
Detailed description
A decline in kidney function after contrast is associated with prolonged hospital stay, adverse cardiac events, and higher mortality both in hospital and in the long term. Deliberate administration of fluids is recommended to reduce the risk of contrast nephropathy. However, data to support specific recommendations are lacking and the optimal fluid regimen remains unclear.
It has been hypothesized that alkalinization of tubular fluid might be beneficial by reducing pH dependent free radical levels. A recent trial found a lower frequency of creatinine rise > 25% within two days of contrast with a 7 hour infusion of isotonic sodium bicarbonate than with saline infusion (Merten GJ, JAMA 2004). However, it remains to be proven that bicarbonate is superior as this trial has a number of methodological flaws.
Comparison: IV 1/6 M sodium bicarbonate OR IV 0.9% saline, each isotonic fluid given at the same rate of sodium administration (3.25 ml/Kg over 1 hour pre-contrast, followed by 1.1 ml/Kg/hr for 6 hours for bicarbonate; 3.5 ml/Kg over 1 hour pre-contrast, followed by 1.2 ml/Kg/hr for 6 hours for saline). Total infusion time 7 hours (for both). Maximum rate of fluid permitted is that for a body weight of 110 Kg. Intra-vascular iso- or low-osmolality contrast in the minimal dose needed to complete the required imaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicarbonate | Experimental | Drug: 1/6 M (166 mEq/L) IV Sodium BicarbonateBicarbonate solution infusion |
| Saline | Active comparator | Drug: 0.9% (154 mEq/L) IV Sodium ChlorideStandard volume expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Booked for cardiac or other non-renal arteriography
- Pre-existing reduced kidney function: Serum Creatinine >= 1.3 \& <= 4 mg/dl (female gender) or >= 1.5 \& <= 5 mg/dl (male gender)
- Age > 18 years
Key exclusion criteria (14 listed)
- GFR MDRD estimate < 15 ml/min/m2
- End-stage renal disease already on dialysis
- Known current Acute Kidney Failure with serum creatinine rise of > 0.5 mg/dl within 24 hours
- Pulmonary edema - current or within 48 hours
- Clinically relevant ascites, edema or other fluid overload
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% (154 mEq/L) IV Sodium ChlorideAlso: Sodium ChlorideSaline solution | Drug | Saline |
| 1/6 M (166 mEq/L) IV Sodium BicarbonateAlso: Sodium BicarbonateBicarbonate solution | Drug | Bicarbonate |
Primary outcome
Development of contrast-induced nephropathy, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast.
Time frame: 48-72 hours
6 secondary outcomes
Group mean change in serum creatinine
Time frame: 48-72 hours
Days in hospital within the week post contrast
Time frame: One week
Requirement for dialysis
Time frame: Two months
Atheroembolic events
Time frame: Two months
Major adverse cardiovascular events
Time frame: Two months
Death
Time frame: Two months
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
- Background: PubMed 15150204Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
- Derived from this study: PubMed 17943084Ravani P, Tripepi G, Pecchini P, Mallamaci F, Malberti F, Zoccali C. Urotensin II is an inverse predictor of death and fatal cardiovascular events in chronic kidney disease. Kidney Int. 2008 Jan;73(1):95-101. doi: 10.1038/sj.ki.5002565. Epub 2007 Oct 17.
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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.
Pietro Ravani, MD, MSc principal investigator
Italian Society of Nephrology
Brendan BJ Barrett, MD, MSc study chair
Memorial University of Newfoundland
Ferruccio Conte, MD study chair
Italian Society of Nephrology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9% (154 mEq/L) IV Sodium Chloride and 1/6 M (166 mEq/L) IV Sodium Bicarbonate in people with Kidney Failure, Acute and Contrast Media, run by Italian Society of Nephrology at 5 sites in Italy.
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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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, CIN, defined as an increase in serum creatinine of 25% or more from pre-intervention baseline to within 48-72 hours after administration of the radiographic contrast. (time frame: 48-72 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 NCT00384995, which also lists 2 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 1 Dec 2010.