X-ray Contrast Media Adverse ReactionBELIEVENCT02449317
Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury
A study testing Bioimpedance guided and standard hydration in people with X-ray Contrast Media Adverse Reaction, run by Mahidol University.
Trial summary
Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- X-ray Contrast Media Adverse Reaction
- What is being tested?
- Bioimpedance guided and standard hydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90 yr
- Chronic kidney disease stage 3 \& 4 (eGFR 15-60 ml/min/m2)
- elective cardiac catheterization
Who cannot join
- Contrast media administration in the past 14 days
- congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease
- Kidney transplant status or RRT
- Emergency cardiac catheterization
- Allergy to radiographic contrast media
- Unstable renal function (change in serum creatinine ≥ 0.5 mg/dl or 25% within 14 days prior to the study
Show all 10Show fewer
- Not inform consent
- left ventricular ejection fraction < 40 %
- Liver cirrhosis child B or C
- Dosage of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker changed in past 2 wk
About this study
Official title: Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast
Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury
Read the detailed description
Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury
- Conditions
- X-ray Contrast Media Adverse Reaction
- Being tested
- Bioimpedance guided, standard hydration
- Keywords
- contrast induced acute kidney injury, bioimpedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance guidedOther
bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water
- extracellular water/total body water < 0.36 : 4 ml/kg/hr
- extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr
- extracellular water/total body water > 0.4 : 1 ml/kg/hr
standard hydrationOther
standard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | standard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours Receives: Other: standard hydration |
| Bioimpedance guided | Experimental | Bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water
* extracellular water/total body water < 0.36 : 4 ml/kg/hr
* extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr
* extracellular water/total body water > 0.4 : 1 ml/kg/hr Receives: Other: Bioimpedance guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine at 48-72 hours after contrast administration
Acute kidney injury
Measured: 48-72 hr
Secondary outcomes (1)
serum creatinine at 2 weeks after contrast administration
Renal replacement therapy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-ray Contrast Media Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkom Nongnuch, MD, Principal investigator, Ramathibodi hospital, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449317
- Sponsor's protocol ID
- 2558/171
- Acronym
- BELIEVE
- Status last verified
- Aug 2017
- First submitted
- 17 May 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast
- ClinicalTrials.gov ID
- NCT02449317
- Acronym / sponsor ID
- BELIEVE / 2558/171
- Conditions
- X-ray Contrast Media Adverse Reaction
- Keywords
- contrast induced acute kidney injury, bioimpedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 May 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.
Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury
Detailed description
Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: standard hydrationstandard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours |
| Bioimpedance guided | Experimental | Other: Bioimpedance guidedBioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water * extracellular water/total body water < 0.36 : 4 ml/kg/hr * extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr * extracellular water/total body water > 0.4 : 1 ml/kg/hr |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-90 yr
- Chronic kidney disease stage 3 \& 4 (eGFR 15-60 ml/min/m2)
- elective cardiac catheterization
Key exclusion criteria (10 listed)
- Contrast media administration in the past 14 days
- congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease
- Kidney transplant status or RRT
- Emergency cardiac catheterization
- Allergy to radiographic contrast media
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 |
|---|---|---|
| Bioimpedance guidedbioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water * extracellular water/total body water < 0.36 : 4 ml/kg/hr * extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr * extracellular water/total body water > 0.4 : 1 ml/kg/hr | Other | Bioimpedance guided |
| standard hydrationstandard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours | Other | Control |
Primary outcome
serum creatinine at 48-72 hours after contrast administration
Time frame: 48-72 hr
Acute kidney injury
1 secondary outcome
serum creatinine at 2 weeks after contrast administration
Time frame: 2 weeks
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 Sep 2017.
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.
Arkom Nongnuch, MD principal investigator
Ramathibodi hospital, Mahidol university
Questions about this trial
What is this clinical trial studying?
A study testing Bioimpedance guided and standard hydration in people with X-ray Contrast Media Adverse Reaction, run by Mahidol University.
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 10 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 Sep 2017. 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?
serum creatinine at 48-72 hours after contrast administration (time frame: 48-72 hr). 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 Sep 2017.