Cardio-Renal SyndromeNCT02405377
Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
A study testing hydration, Visipaque and 0.9% sodium chloride fluid administration in people with Cardio-Renal Syndrome, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive sufficient hydration before application of contrast to prevent CIN, but hydration could obviously increase the preload for congestive heart failure (CHF) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardio-Renal Syndrome
- What is being tested?
- hydration, Visipaque and 0.9% sodium chloride fluid administration
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Feb 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
- moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
- patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.
Who cannot join
- hemodialysis-dependent patients;
- complicated with severe short-term progressive disease;
- Patients < 18 years;
- pregnancy;
- emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
- exposure to radiographic contrast media within the previous 7 days;
- acute decompensated heart failure.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: Chinese People's Liberation Army General Hospital
Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive sufficient hydration before application of contrast to prevent CIN, but hydration could obviously increase the preload for congestive heart failure (CHF) patients. It is important to make an individual hydration protocol for patients with dysfunction of heart and renal to reduce the incidence rate of CIN. This prospective, randomized, double-blind, comparative clinical trial randomly selected 264 patients with estimated glomerular filtration rate, (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary angiography to receive either the convention hydration (n=132) or the central venous pressure (CVP) guided hydration (n=132).
Read the detailed description
Investigators enrolled 264 patients from February 2014 to February 2015, the principal inclusion criterion included CHF: left ventricular eject fraction (LVEF) <= 50%; moderate to severe CKD was diagnosed as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment, patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. We randomly assigned eligible patients in a 1:1 ratio to either CVP guided therapy or a standard hydration administration protocol. Investigators used the same fluid type commercially available 0.9% sodium chloride in all patients. Investigators monitored the CVP by placing an 5-French catheter in the jugular vein. Investigators recorded the CVP with commercially available haemodynamic monitoring software. In the CVP guided group the fluid rate was adjusted according to the CVP as follows: 3 mL/kg/h for CVP lower than 6 mmHg, 1.5 mL/kg/h for pressure of 6-12 mmHg, and 1mL/kg/h for pressure higher than 12 mmHg. The control group was hydrated at 1 mL/kg per h. The fluid rate was set at the start of the procedure (before contrast exposure). Thus, both study groups received intravenous fluids for the same duration but at different rates. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium.
Primary end point of the study was the incidence of CIN: The median peak increase in serum creatinine concentration between day 0 (when contrast was administered) and day 7. Definition of CIN was an absolute increase in serum creatinine (SCr) >0.5 mg/dl or a relative increase >25% compared to baseline SCr. Definition of non-Q-wave myocardial infarction was a creatine kinase-myocardial band enzyme elevation 3 times the upper normal value without new Q waves on the electrocardiogram. Definition of Q-wave myocardial infarction was presence of new pathologic Q waves on an electrocardiogram in conjunction with an elevation in creatine kinase greater than 3 times the normal value. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee. Each patient was contacted in every week after administration of the contrast, investigated if dialysis or main cardiovascular events (myocardial infarction,acute heart failure and death), and record any adverse events.
- Conditions
- Cardio-Renal Syndrome
- Being tested
- hydration, Visipaque, 0.9% sodium chloride fluid administration, 5-French catheter
- Keywords
- contrast-induced nephropathy, hydration, Percutaneous coronary intervention
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrationProcedure or surgery
Before the coronary procedures, investigators used the same 0.9% sodium chloride for hydration in all patients. Investigator monitored the central venous pressure (CVP) by placing an 5-French catheter in the jugular vein in the intervention group, and administration fluid rate was adjusted according to the CVP as follows: 3 ml/kg/h for CVP lower than 6 mmHg, 1.5 ml/kg/h for pressure of 6-12 mmHg, and 1ml/kg/h for pressure higher than 12 mmHg. The control group was hydrated with 0.9% sodium chloride at 1 ml/kg/h, continued for the duration of 12 h post-procedure in both groups. Thus, both study groups received intravenous fluids for the same duration but at different rates. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium.
VisipaqueDrug
All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
0.9% sodium chloride fluid administrationDrug
5-French catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| CVP guided hydration | Experimental | The fluid rate was adjusted according to the CVP dynamically Receives: Procedure: hydration; Drug: Visipaque; Drug: 0.9% sodium chloride fluid administration; Device: 5-French catheter |
| Control | Active comparator | The control group was hydrated at 1 mL/kg per h. Receives: Procedure: hydration; Drug: Visipaque; Drug: 0.9% sodium chloride fluid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy postoperation
a peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
Measured: 7 days
Secondary outcomes (1)
Composite measure of dialysis or main cardiovascular events
dialysis, myocardial infarction, heart failure and all-cause death
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardio-Renal SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian geng, Chinese PLA General Hospital
- Investigators
- Dai Yun Chen, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405377
- Sponsor's protocol ID
- 14KMM02
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schilp J, de Blok C, Langelaan M, Spreeuwenberg P, Wagner C. Guideline adherence for identification and hydration of high-risk hospital patients for contrast-induced nephropathy. BMC Nephrol. 2014 Jan 6;15:2. doi: 10.1186/1471-2369-15-2.
PubMed 24393347Balemans CE, Reichert LJ, van Schelven BI, van den Brand JA, Wetzels JF. Epidemiology of contrast material-induced nephropathy in the era of hydration. Radiology. 2012 Jun;263(3):706-13. doi: 10.1148/radiol.12111667. Epub 2012 Apr 24.
PubMed 22535561Marenzi G, Ferrari C, Marana I, Assanelli E, De Metrio M, Teruzzi G, Veglia F, Fabbiocchi F, Montorsi P, Bartorelli AL. Prevention of contrast nephropathy by furosemide with matched hydration: the MYTHOS (Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention) trial. JACC Cardiovasc Interv. 2012 Jan;5(1):90-7. doi: 10.1016/j.jcin.2011.08.017.
PubMed 22230154Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
PubMed 15464318Torigoe K, Tamura A, Watanabe T, Kadota J. 20-Hour preprocedural hydration is not superior to 5-hour preprocedural hydration in the prevention of contrast-induced increases in serum creatinine and cystatin C. Int J Cardiol. 2013 Sep 1;167(5):2200-3. doi: 10.1016/j.ijcard.2012.05.122. Epub 2012 Jun 19.
PubMed 22717305Duan N, Zhao J, Li Z, Dong P, Wang S, Zhao Y, Wang L, Wang H. Furosemide with saline hydration for prevention of contrast-induced nephropathy in patients undergoing coronary angiography: a meta-analysis of randomized controlled trials. Med Sci Monit. 2015 Jan 23;21:292-7. doi: 10.12659/MSM.892446.
PubMed 25613017Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.
PubMed 24856027Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.
PubMed 26685074
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese People's Liberation Army General Hospital
- ClinicalTrials.gov ID
- NCT02405377
- Acronym / sponsor ID
- 14KMM02
- Conditions
- Cardio-Renal Syndrome
- Keywords
- contrast-induced nephropathy, hydration, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Apr 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.
Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive sufficient hydration before application of contrast to prevent CIN, but hydration could obviously increase the preload for congestive heart failure (CHF) patients. It is important to make an individual hydration protocol for patients with dysfunction of heart and renal to reduce the incidence rate of CIN. This prospective, randomized, double-blind, comparative clinical trial randomly selected 264 patients with estimated glomerular filtration rate, (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary angiography to receive either the convention hydration (n=132) or the central venous pressure (CVP) guided hydration (n=132).
Detailed description
Investigators enrolled 264 patients from February 2014 to February 2015, the principal inclusion criterion included CHF: left ventricular eject fraction (LVEF) <= 50%; moderate to severe CKD was diagnosed as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment, patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. We randomly assigned eligible patients in a 1:1 ratio to either CVP guided therapy or a standard hydration administration protocol. Investigators used the same fluid type commercially available 0.9% sodium chloride in all patients. Investigators monitored the CVP by placing an 5-French catheter in the jugular vein. Investigators recorded the CVP with commercially available haemodynamic monitoring software. In the CVP guided group the fluid rate was adjusted according to the CVP as follows: 3 mL/kg/h for CVP lower than 6 mmHg, 1.5 mL/kg/h for pressure of 6-12 mmHg, and 1mL/kg/h for pressure higher than 12 mmHg. The control group was hydrated at 1 mL/kg per h. The fluid rate was set at the start of the procedure (before contrast exposure). Thus, both study groups received intravenous fluids for the same duration but at different rates. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium.
Primary end point of the study was the incidence of CIN: The median peak increase in serum creatinine concentration between day 0 (when contrast was administered) and day 7. Definition of CIN was an absolute increase in serum creatinine (SCr) >0.5 mg/dl or a relative increase >25% compared to baseline SCr. Definition of non-Q-wave myocardial infarction was a creatine kinase-myocardial band enzyme elevation 3 times the upper normal value without new Q waves on the electrocardiogram. Definition of Q-wave myocardial infarction was presence of new pathologic Q waves on an electrocardiogram in conjunction with an elevation in creatine kinase greater than 3 times the normal value. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee. Each patient was contacted in every week after administration of the contrast, investigated if dialysis or main cardiovascular events (myocardial infarction,acute heart failure and death), and record any adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVP guided hydration | Experimental | Procedure: hydration, Drug: Visipaque, Drug: 0.9% sodium chloride fluid administration, Device: 5-French catheterThe fluid rate was adjusted according to the CVP dynamically |
| Control | Active comparator | Procedure: hydration, Drug: Visipaque, Drug: 0.9% sodium chloride fluid administrationThe control group was hydrated at 1 mL/kg per h. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
- moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
- patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.
Key exclusion criteria (7 listed)
- hemodialysis-dependent patients;
- complicated with severe short-term progressive disease;
- Patients < 18 years;
- pregnancy;
- emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
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 |
|---|---|---|
| hydrationBefore the coronary procedures, investigators used the same 0.9% sodium chloride for hydration in all patients. Investigator monitored the central venous pressure (CVP) by placing an 5-French catheter in the jugular vein in the intervention group, and administration fluid rate was adjusted according to the CVP as follows: 3 ml/kg/h for CVP lower than 6 mmHg, 1.5 ml/kg/h for pressure of 6-12 mmHg, and 1ml/kg/h for pressure higher than 12 mmHg. The control group was hydrated with 0.9% sodium chloride at 1 ml/kg/h, continued for the duration of 12 h post-procedure in both groups. Thus, both study groups received intravenous fluids for the same duration but at different rates. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium. | Procedure or surgery | CVP guided hydration, Control |
| VisipaqueAll study participants received intra-arterial (320 mg I/ml; GE Healthcare) | Drug | CVP guided hydration, Control |
| 0.9% sodium chloride fluid administration | Drug | CVP guided hydration, Control |
| 5-French catheter | Device | CVP guided hydration |
Primary outcome
Contrast induced nephropathy postoperation
Time frame: 7 days
a peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
1 secondary outcome
Composite measure of dialysis or main cardiovascular events
Time frame: 90 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 Apr 2015.
- Background: PubMed 24393347Schilp J, de Blok C, Langelaan M, Spreeuwenberg P, Wagner C. Guideline adherence for identification and hydration of high-risk hospital patients for contrast-induced nephropathy. BMC Nephrol. 2014 Jan 6;15:2. doi: 10.1186/1471-2369-15-2.
- Background: PubMed 22535561Balemans CE, Reichert LJ, van Schelven BI, van den Brand JA, Wetzels JF. Epidemiology of contrast material-induced nephropathy in the era of hydration. Radiology. 2012 Jun;263(3):706-13. doi: 10.1148/radiol.12111667. Epub 2012 Apr 24.
- Background: PubMed 22230154Marenzi G, Ferrari C, Marana I, Assanelli E, De Metrio M, Teruzzi G, Veglia F, Fabbiocchi F, Montorsi P, Bartorelli AL. Prevention of contrast nephropathy by furosemide with matched hydration: the MYTHOS (Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention) trial. JACC Cardiovasc Interv. 2012 Jan;5(1):90-7. doi: 10.1016/j.jcin.2011.08.017.
- Background: PubMed 15464318Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
- Background: PubMed 22717305Torigoe K, Tamura A, Watanabe T, Kadota J. 20-Hour preprocedural hydration is not superior to 5-hour preprocedural hydration in the prevention of contrast-induced increases in serum creatinine and cystatin C. Int J Cardiol. 2013 Sep 1;167(5):2200-3. doi: 10.1016/j.ijcard.2012.05.122. Epub 2012 Jun 19.
- Background: PubMed 25613017Duan N, Zhao J, Li Z, Dong P, Wang S, Zhao Y, Wang L, Wang H. Furosemide with saline hydration for prevention of contrast-induced nephropathy in patients undergoing coronary angiography: a meta-analysis of randomized controlled trials. Med Sci Monit. 2015 Jan 23;21:292-7. doi: 10.12659/MSM.892446.
- Results publication: PubMed 24856027Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.
- Derived from this study: PubMed 26685074Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.
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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.
Dai Yun Chen, MD study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydration, Visipaque and 0.9% sodium chloride fluid administration in people with Cardio-Renal Syndrome, run by Chinese PLA General Hospital at 1 site in China.
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 7 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 Apr 2015. 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 China. 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.
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 postoperation (time frame: 7 days). 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 NCT02405377, which also lists 8 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 Apr 2015.