Radiographic Contrast Agent NephropathyPhase 4NCT02137863

Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

A Phase 4 study testing Dexmedetomidine and 0.9 % NaCl in people with Radiographic Contrast Agent Nephropathy, run by TC Erciyes University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients. 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?: Dexmedetomidine and 0.9 % NaCl
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Jun 2011to Jul 2012
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

Scheduled for percutaneous coronary angiography
> 18 yo
Diabetic patients
Creatinin value < 3 mg/dl

Who cannot join

Contrast agent hypersensitivity
Pregnant patients
Creatinin value ≥3mg/dl
patients have acute renal failure

About this study

Official title: Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy

The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients.

Read the detailed description

Contrast nephropathy may occur after using intravenous contrast media and may result in acute renal failure. Contrast nephropathy usually reversible but in some cases it can be permanent. This situation increase the time of hospitalization and mortality of the patients. Although the only proved prevention from contrast nephropathy method is hydration, infusion of dexmedetomidine may keep the renal functions.

Conditions: Radiographic Contrast Agent Nephropathy
Being tested: Dexmedetomidine, 0.9 % NaCl
Keywords: Contrast induced nephropathy, Diabetes Mellitus, Dexmedetomidine
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Precedex
Intravenously 1μg/kg/10min administered just before the procedure.
1 μg/kg/h administered during the angiography and was continued 1 hour after the angiography.
0.9 % NaClDrug
Also called Normal Saline
During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.
0.9 % NaClDrug
Also called Normal Saline
100 ml/10min infusion just before the angiography
1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure

Study groups in NCT02137863
Study group	Role	What they receive
Control	Placebo comparator	Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours. During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered. 100 ml/10min 0.9 % NaCl administered intravenously just before the angiography. 1 ml/kg/h 0.9 % sodium chloride administered intravenously during the procedure and was continued 1 hour after the angiography. Receives: Drug: 0.9 % NaCl
Dexmedetomidine	Active comparator	Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours. During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered. Dexmedetomidine was diluted as 1 μg/ml. 1 μg/kg/10min dexmedetomidine administered intravenously just before the angiography. 1 μg/kg/h dexmedetomidine administered intravenously during the procedure and was continued 1 hour after the angiography. Receives: Drug: Dexmedetomidine; Drug: 0.9 % NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin
Measured: 1 day (from start of angioplasty till discharge from the hospital)

Secondary outcomes (4)

blood pressure
Measured: 1 day (from start of angiography till discharge from the hospital)
Heart rate
Measured: 1 day (from start of angiography till discharge from the hospital)
Blood electrolyte levels ( sodium, potassium, chloride)
Measured: before the angiography and just before the discharge from hospital
complete blood count
Measured: before the angiography and just before the discharge from hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jul 2012

First posted14 May 2014 (estimated)
Study startJun 2011
Primary completionJun 2012
Study completionJul 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.
More trials run by TC Erciyes 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02137863
Sponsor's protocol ID: 2011/345
Status last verified: May 2014
First submitted: 13 Jan 2014
Last updated: 14 May 2014
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy
ClinicalTrials.gov ID: NCT02137863
Acronym / sponsor ID: 2011/345
Conditions: Radiographic Contrast Agent Nephropathy
Keywords: Contrast induced nephropathy, Diabetes Mellitus, Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: Jun 2011
Primary completion: Jun 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 14 May 2014 (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.

The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	Placebo comparator	Drug: 0.9 % NaClBefore the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours. During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered. 100 ml/10min 0.9 % NaCl administered intravenously just before the angiography. 1 ml/kg/h 0.9 % sodium chloride administered intravenously during the procedure and was continued 1 hour after the angiography.
Dexmedetomidine	Active comparator	Drug: Dexmedetomidine, Drug: 0.9 % NaClBefore the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours. During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered. Dexmedetomidine was diluted as 1 μg/ml. 1 μg/kg/10min dexmedetomidine administered intravenously just before the angiography. 1 μg/kg/h dexmedetomidine administered intravenously during the procedure and was continued 1 hour after the angiography.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Scheduled for percutaneous coronary angiography
> 18 yo
Diabetic patients
Creatinin value < 3 mg/dl

Key exclusion criteria (4 listed)

Contrast agent hypersensitivity
Pregnant patients
Creatinin value ≥3mg/dl
patients have acute renal failure

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
DexmedetomidineAlso: PrecedexIntravenously 1μg/kg/10min administered just before the procedure. 1 μg/kg/h administered during the angiography and was continued 1 hour after the angiography.	Drug	Dexmedetomidine
0.9 % NaClAlso: Normal SalineDuring 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.	Drug	Control, Dexmedetomidine
0.9 % NaClAlso: Normal Saline100 ml/10min infusion just before the angiography 1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure	Drug	Control

Primary outcome

Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin
Time frame: 1 day (from start of angioplasty till discharge from the hospital)

4 secondary outcomes

blood pressure
Time frame: 1 day (from start of angiography till discharge from the hospital)
Heart rate
Time frame: 1 day (from start of angiography till discharge from the hospital)
Blood electrolyte levels ( sodium, potassium, chloride)
Time frame: before the angiography and just before the discharge from hospital
complete blood count
Time frame: before the angiography and just before the discharge from hospital

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 14 May 2014.

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.

Aynur Akın, Prof study chair

TC Erciyes University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and 0.9 % NaCl in people with Radiographic Contrast Agent Nephropathy, run by TC Erciyes 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 4 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 14 May 2014. 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. 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 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 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?

Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin (time frame: 1 day (from start of angioplasty till discharge from the hospital)). 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 NCT02137863.

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 14 May 2014.