Radiographic Contrast Agent NephropathyNCT02643602
Does Bicarbonate in Addition to Theophylline Reduce CIN?
A study testing Hydration with bicarbonate in addition to theophylline and Hydration with sodium chloride in addition to theophylline in people with Radiographic Contrast Agent Nephropathy, run by Technical University of Munich.
Trial summary
Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy
- What is being tested?
- Hydration with bicarbonate in addition to theophylline and Hydration with sodium chloride in addition to theophylline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Dec 2012
- Phase
- Interventional
- 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
- Increased risk for contrast induced nephropathy defined as:
- Serum creatinine level ≥ 1.1 mg/dl OR
- Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)
Who cannot join
- pre-existing renal replacement therapy
- unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
- contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
- additional interventions that might influence renal function
About this study
Official title: Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?
Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.
Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- Hydration with bicarbonate in addition to theophylline, Hydration with sodium chloride in addition to theophylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration with bicarbonate in addition to theophyllineOther
0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours
Hydration with sodium chloride in addition to theophyllineOther
0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Bicarbonate and theophylline | Experimental | Hydration with bicarbonate in addition to theophylline Receives: Other: Hydration with bicarbonate in addition to theophylline |
| Sodium and theophylline | Active comparator | Hydration with sodium chloride in addition to theophylline Receives: Other: Hydration with sodium chloride in addition to theophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy
Raise in serum creatinine of ≥25% or ≥0.5 mg/dl
Measured: 48 hours
Secondary outcomes (9)
Change of serum creatinine levels over time
Measured: 48 hours
Change of creatinine clearance over time
Measured: 48 hours
Change in blood pH
Measured: 48 hours
Change in blood bicarbonate-concentration
Measured: 48 hours
Change in blood sodium-concentration
Measured: 48 hours
Change in urine pH
Measured: 48 hours
Change in urine bicarbonate-concentration
Measured: 48 hours
Change in urine pH sodium-concentration
Measured: 48 hours
Incidence of patients with need for dialysis
The patients medical record was reviewed to determine whether dialysis was performed within 30 days after contrast media application.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2005
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiographic Contrast Agent NephropathyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Huber, M.D., Principal investigator, 2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643602
- Sponsor's protocol ID
- NaBicTheo
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?
- ClinicalTrials.gov ID
- NCT02643602
- Acronym / sponsor ID
- NaBicTheo
- Conditions
- Radiographic Contrast Agent Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Dec 2015 (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.
Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.
Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.
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 |
|---|---|---|
| Bicarbonate and theophylline | Experimental | Other: Hydration with bicarbonate in addition to theophyllineHydration with bicarbonate in addition to theophylline |
| Sodium and theophylline | Active comparator | Other: Hydration with sodium chloride in addition to theophyllineHydration with sodium chloride in addition to theophylline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Serum creatinine level ≥ 1.1 mg/dl OR
- Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)
Key exclusion criteria (4 listed)
- pre-existing renal replacement therapy
- unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
- contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
- additional interventions that might influence renal function
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 |
|---|---|---|
| Hydration with bicarbonate in addition to theophylline0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours | Other | Bicarbonate and theophylline |
| Hydration with sodium chloride in addition to theophylline0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours | Other | Sodium and theophylline |
Primary outcome
Contrast induced nephropathy
Time frame: 48 hours
Raise in serum creatinine of ≥25% or ≥0.5 mg/dl
9 secondary outcomes
Change of serum creatinine levels over time
Time frame: 48 hours
Change of creatinine clearance over time
Time frame: 48 hours
Change in blood pH
Time frame: 48 hours
Change in blood bicarbonate-concentration
Time frame: 48 hours
Change in blood sodium-concentration
Time frame: 48 hours
Change in urine pH
Time frame: 48 hours
Change in urine bicarbonate-concentration
Time frame: 48 hours
Change in urine pH sodium-concentration
Time frame: 48 hours
Incidence of patients with need for dialysis
Time frame: 30 days
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 1 Jan 2016.
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.
Wolfgang Huber, M.D. principal investigator
2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
Questions about this trial
What is this clinical trial studying?
A study testing Hydration with bicarbonate in addition to theophylline and Hydration with sodium chloride in addition to theophylline in people with Radiographic Contrast Agent Nephropathy, run by Technical University of Munich.
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 4 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contrast induced nephropathy (time frame: 48 hours). 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 1 Jan 2016.