Cardio-Renal SyndromeNCT02959281
Bioimpedance and Hand-held Echocardiographay for Clinical Decision-making in Treatment of Cardio-renal Syndrome Type I
A study testing Providing caring physicians with hemodynamic variables in people with Cardio-Renal Syndrome, run by HaEmek Medical Center, Israel.
Trial summary
The purpose of this study is to investigate whether hemodynamic data obtained by a noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type I (CRS1) improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cardio-Renal Syndrome
- What is being tested?
- Providing caring physicians with hemodynamic variables
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 16 Jun 2019
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted for acute decompensation of heart failure and developed cardiorenal syndrome (all three criteria below are required):
- Evidence of heart failure defined by either (i) or (ii) and (iii), where:
- is clinical complaints of dyspnea or leg swelling or fatigue (ii) is clinical findings of pulmonary rales, leg edema, or congestion on chest film (iii) is recent (within 1 year of admission) echocardiographic examination demonstrating heart failure B. Patient as in A (above) whos serum creatinine level on admission is 0.3 mg% greater than patient's baseline.
- Patient capable of submitting informed consent
Who cannot join
- Other causes for dyspnea or leg edema (e.g. exacerbation of COPD, pneumonia, liver cirrhosis, hypoalbuminemia, nephrotic syndrome)
- other causes for acute renal failure (e.g. contrast media nephropathy 10 days prior to admission, use of NSAIDS or antibiotics (aminoglycosides, quinolones), diarrhea, vomiting, rhabdomyolysis, seizures, sepsis.
- Anemia (Hb<8 gr%)
- significant bleeding (upper or lower GI, hemoptysis)
- BMI>40, or BMI<18
- Signs of a new myocardial infarction by EKG, and increase in troponin levels to levels 1.5 above baseline levels.
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- Hypothyroidism
- Addison's disease
- patient on Hemo- or peritoneal dialysis
- Mechanical ventillation
About this study
Official title: The Application of Bio-impedance System NICAS and Hand-held Echocardiographic System (VSCAN) as Tools for Clinical Decision-making in the Treatment of In-patients With Cardio-renal Syndrome Type I
The purpose of this study is to investigate whether hemodynamic data obtained by a noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to the caring physician will improve management of CRS1 patients.
Read the detailed description
Patients admitted to the hospital due to acute decompensation of heart failure (ADHF) may manifest some deterioration in their renal function. The latter is associated with unfavorable outcomes: prolonged hospitalization and death. Cardiorenal syndrome type 1 (CRS1) is defined as a deterioration in renal function manifested by an increase in serum creatinine level by >0.3 mg% compared to patient's baseline level. The etiology of CRS1 is not clear and may be related to body fluid overload congesting the kidneys or dehydration reducing perfusion to the kidneys. Body fluid status is affected by diuretics. Presently, the practitioner has no objective data to assess whether CRS1 resulted from fluid overload or dehydration.
In this study investigators plan to measure hemodynamic parameters from all patients admitted with CRS1 to our department. Parameters will be measured using the noninvasive bio-impedance system (NICAS). Randomly, patients will be allocated to either a study or control group. In the study group, the hemodynamic variables of the NICAS system will be available to the caring physicians. The physicians will use the data according to their discretion. The hemodynamic system is a decision making supporting system and therefore the physician may use the data according to his/her understanding. In the control group, the hemodynamic variables of the NICAS system will not be available to the caring physicians.
We hypothesize that using the NICAS system as a decision making supporting system will improve patient management by decreasing length of hospitalization, and shortening the time interval to reverse creatinine to its baseline level.
- Conditions
- Cardio-Renal Syndrome
- Being tested
- Providing caring physicians with hemodynamic variables
- 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.
Providing caring physicians with hemodynamic variablesOther
NICAS electrodes are applied to the skin of the forearm bilaterally (similar to EKG electrodes). Conductors, attached to the electrodes, connect the patient with the measuring system.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic data available | Experimental | Providing caring physicians with hemodynamic variables measured using the NICAS system. Receives: Other: Providing caring physicians with hemodynamic variables |
| Hemodynamic data not available | No intervention | Hemodynamic variables measured using the NICAS system will not be provided to the caring physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean hospitalization duration (in days)
Time of hospitalization is defined from time of recruitment till the time patient is ready for discharge.
Measured: 2 months
Secondary outcomes (2)
Time from maximum serum creatinine level to patient's discharge
Time from maximum serum creatinine level to time when patient is ready for discharge
Measured: 2 months
Maximum difference in serum creatinine level
This outcome is defined by the maximum serum creatinine level obtained during the followup of the patient minus patient's mean serum creatinine level
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start1 Jun 2018
- Primary completion16 Jun 2019
- Study completion16 Jun 2019
Why it stopped: Enrollement failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardio-Renal SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Dori, HaEmek Medical Center, Israel
- Investigators
- Guy Dori, MD, DSc, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959281
- Sponsor's protocol ID
- EMC-0081-16
- Status last verified
- Jun 2019
- First submitted
- 7 Nov 2016
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators do not plan to share the IPD with any body. After completion of study we plan to publish results.
Publications
Ronco C, Cicoira M, McCullough PA. Cardiorenal syndrome type 1: pathophysiological crosstalk leading to combined heart and kidney dysfunction in the setting of acutely decompensated heart failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. doi: 10.1016/j.jacc.2012.01.077. Epub 2012 Jul 25.
PubMed 22840531
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Bio-impedance System NICAS and Hand-held Echocardiographic System (VSCAN) as Tools for Clinical Decision-making in the Treatment of In-patients With Cardio-renal Syndrome Type I
- ClinicalTrials.gov ID
- NCT02959281
- Acronym / sponsor ID
- EMC-0081-16
- Conditions
- Cardio-Renal Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollement failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 16 Jun 2019 (actual)
- First posted
- 9 Nov 2016 (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 purpose of this study is to investigate whether hemodynamic data obtained by a noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to the caring physician will improve management of CRS1 patients.
Detailed description
Patients admitted to the hospital due to acute decompensation of heart failure (ADHF) may manifest some deterioration in their renal function. The latter is associated with unfavorable outcomes: prolonged hospitalization and death. Cardiorenal syndrome type 1 (CRS1) is defined as a deterioration in renal function manifested by an increase in serum creatinine level by >0.3 mg% compared to patient's baseline level. The etiology of CRS1 is not clear and may be related to body fluid overload congesting the kidneys or dehydration reducing perfusion to the kidneys. Body fluid status is affected by diuretics. Presently, the practitioner has no objective data to assess whether CRS1 resulted from fluid overload or dehydration.
In this study investigators plan to measure hemodynamic parameters from all patients admitted with CRS1 to our department. Parameters will be measured using the noninvasive bio-impedance system (NICAS). Randomly, patients will be allocated to either a study or control group. In the study group, the hemodynamic variables of the NICAS system will be available to the caring physicians. The physicians will use the data according to their discretion. The hemodynamic system is a decision making supporting system and therefore the physician may use the data according to his/her understanding. In the control group, the hemodynamic variables of the NICAS system will not be available to the caring physicians.
We hypothesize that using the NICAS system as a decision making supporting system will improve patient management by decreasing length of hospitalization, and shortening the time interval to reverse creatinine to its baseline level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic data available | Experimental | Other: Providing caring physicians with hemodynamic variablesProviding caring physicians with hemodynamic variables measured using the NICAS system. |
| Hemodynamic data not available | No intervention | –Hemodynamic variables measured using the NICAS system will not be provided to the caring physicians. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient admitted for acute decompensation of heart failure and developed cardiorenal syndrome (all three criteria below are required):
- Evidence of heart failure defined by either (i) or (ii) and (iii), where:
- is clinical complaints of dyspnea or leg swelling or fatigue (ii) is clinical findings of pulmonary rales, leg edema, or congestion on chest film (iii) is recent (within 1 year of admission) echocardiographic examination demonstrating heart failure B. Patient as in A (above) whos serum creatinine level on admission is 0.3 mg% greater than patient's baseline.
- Patient capable of submitting informed consent
Key exclusion criteria (10 listed)
- Other causes for dyspnea or leg edema (e.g. exacerbation of COPD, pneumonia, liver cirrhosis, hypoalbuminemia, nephrotic syndrome)
- other causes for acute renal failure (e.g. contrast media nephropathy 10 days prior to admission, use of NSAIDS or antibiotics (aminoglycosides, quinolones), diarrhea, vomiting, rhabdomyolysis, seizures, sepsis.
- Anemia (Hb<8 gr%)
- significant bleeding (upper or lower GI, hemoptysis)
- BMI>40, or BMI<18
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 |
|---|---|---|
| Providing caring physicians with hemodynamic variablesNICAS electrodes are applied to the skin of the forearm bilaterally (similar to EKG electrodes). Conductors, attached to the electrodes, connect the patient with the measuring system. | Other | Hemodynamic data available |
Primary outcome
Mean hospitalization duration (in days)
Time frame: 2 months
Time of hospitalization is defined from time of recruitment till the time patient is ready for discharge.
2 secondary outcomes
Time from maximum serum creatinine level to patient's discharge
Time frame: 2 months
Maximum difference in serum creatinine level
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Background: PubMed 22840531Ronco C, Cicoira M, McCullough PA. Cardiorenal syndrome type 1: pathophysiological crosstalk leading to combined heart and kidney dysfunction in the setting of acutely decompensated heart failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. doi: 10.1016/j.jacc.2012.01.077. Epub 2012 Jul 25.
- Individual participant dataSharing planned: No. Investigators do not plan to share the IPD with any body. After completion of study we plan to publish results.
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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.
Guy Dori, MD, DSc principal investigator
haemek medical center
Questions about this trial
What is this clinical trial studying?
A study testing Providing caring physicians with hemodynamic variables in people with Cardio-Renal Syndrome, run by HaEmek Medical Center, Israel.
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 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: withdrawn, as of the sponsor's last update on 28 Jun 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean hospitalization duration (in days) (time frame: 2 months). 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 NCT02959281, which also lists 1 linked publication.
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 28 Jun 2019.