Other Diagnoses and ConditionsNCT01547650
Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium
An observational study of Other Diagnoses and Conditions, run by Nagaoka Red Cross Hospital at 1 site in Japan.
Trial summary
Rossi NF \& Schrier RW reported that for having differential diagnosis in hyponatremic state, it is important to have a grasp of extra cellular fluid (ECF) volume. However, recent works showed that it is not easy to estimate the ECF state using by physical findings and by usual laboratory methods. Damaraju SC et al. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Diagnoses and Conditions
- What is being tested?
- Calculated CVP by using cardiac echogram
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2012to Feb 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with disorders of fluid with sodium including cerebral salt wasting syndrome (CSWS), syndrome of inappropriate antidiuretic hormone secretion (SIADH), primary polydipsia (PP), central diabetes insipidus (CDI) and others * Patients more than 18 years old (gender is disregarded) * Healthy subjects more than 18 years old (gender is disregarded)
Who may be able to join
- Patients with disorders of fluid with sodium including cerebral salt wasting syndrome (CSWS), syndrome of inappropriate antidiuretic hormone secretion (SIADH), primary polydipsia (PP), central diabetes insipidus (CDI) and others
- Patients more than 18 years old (gender is disregarded)
- Healthy subjects more than 18 years old (gender is disregarded)
Who cannot join
- Patients with a serious complication in the heart, liver or kidney
- Pregnant or possibly pregnant patients, or lactating patients
- Patients complicated with a malignant tumor at present.
- Patients participating in other clinical study.
- Other than the above, patients judged inappropriate as the subjects of this study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Rossi NF \& Schrier RW reported that for having differential diagnosis in hyponatremic state, it is important to have a grasp of extra cellular fluid (ECF) volume. However, recent works showed that it is not easy to estimate the ECF state using by physical findings and by usual laboratory methods.
Damaraju SC et al. first demonstrated that measuring central venous pressure (CVP) is significant to evaluate the ECF state in hyponatremic patients with intracranial diseases. Accordingly, it may be useful to measure the CVP in the hyponatremic patients. However, usually it is difficult to measure the CVP in all patients with hyponatremia because that the method is due to invasive procedure. With recently development, it is possible to estimate the CVP calculation using cardiac echogram without invasion. However, it is not clear that an evaluation by using such echogram estimates the state of ECF volume in hyponatremic patients.
Read more
Therefore, the investigators examine whether the CVP calculation by using cardiac echogram by Marcelino P et al. method without invasion is estimated such condition in hyponatremic patients before and after treatments.
As the primary endpoint, the VCI index values is investigated and compared with each group before and after correction of disorders of fluid with sodium. Furthermore, some variables including sodium, potassium, chloride, creatinine, BUN, uric acid, osmolality in blood and urine and plasma vasopressin are investigated and compared with each group before and after correction of disorders of fluid with sodium.
Read the detailed description
Calculated CVP value as VCI (vena cava inferior) index by Marcelino P et al. method-they reported that VCI index using several echocardiographic parameters measured. A transthoracic echocardiographic study was performed using an Aloka SSD 2200 echocardiograph fitted with 2.5MHz probe with continuous-wave，pulsed and color Doppler (Japan). Using pulsed Doppler，each parameter is measured as following; the deceleration rime of E wave of tricuspid inflow，the gradient between right ventricle (RV) and right atrium (RA) by continuous Doppler，the VCI variation from the corresponding maximum expiratory diameter (measured at 2 cm from the RA and in dorsal decubitus) to its diameter during inspiration. All measurements were taken at the end-expiration in order to standardize the samples. VCI index = [tricuspid E deceleration (ms)] x 0.11 + [RV/RA gradient (mmHg)] x 0.16 - [VCI variation (mm)] (VCI, vena cava inferior; tricuspid E, tricuspid E wave; RV, right ventricle, RA, right atrium).
Na, Cl, K, creatinine, BUN and uric acid in serum and urine were measured by the usual methods before and after the correction of plasma volume. Further, osmolality and vasopressin in plasma and osmolality in urine were also measured by the usual methods.
- Conditions
- Other Diagnoses and Conditions
- Being tested
- Calculated CVP by using cardiac echogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculated CVP by using cardiac echogramOther
Before and after the correction of plasma volume
| Study group | Role | What they receive |
|---|---|---|
| SIADH, CSWS, CDI, PP, DIH, HF | CSWS (cerebral salt wasting syndrome), SIADH (syndrome of inappropriate ADH) , CDI (central diabetes insipidus), PP (primary polydipsia), DIH (drug-induced hyponatremia), HF (heart failure with hyponatremia) Receives: Other: Calculated CVP by using cardiac echogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated CVP by using cardiac echogram
Measured: within the first 30 days (plus or minus 3 days) after correcting status of plasma volume
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2023 (estimated)
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 Other Diagnoses and ConditionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagaoka Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyuzi Kamoi, Nagaoka Red Cross Hospital
- Investigators
- Kyuzi Kamoi, MD, Principal investigator, Nagaoka Red Cross Hospital and University of Niigata Prefecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547650
- Sponsor's protocol ID
- 3-Kamoi
- Status last verified
- Mar 2012
- First submitted
- 23 Feb 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Damaraju SC, Rajshekhar V, Chandy MJ. Validation study of a central venous pressure-based protocol for the management of neurosurgical patients with hyponatremia and natriuresis. Neurosurgery. 1997 Feb;40(2):312-6; discussion 316-7. doi: 10.1097/00006123-199702000-00015.
PubMed 9007863
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium
- ClinicalTrials.gov ID
- NCT01547650
- Acronym / sponsor ID
- 3-Kamoi
- Conditions
- Other Diagnoses and Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nagaoka Red Cross HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 8 Mar 2012 (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.
Rossi NF \& Schrier RW reported that for having differential diagnosis in hyponatremic state, it is important to have a grasp of extra cellular fluid (ECF) volume. However, recent works showed that it is not easy to estimate the ECF state using by physical findings and by usual laboratory methods.
Damaraju SC et al. first demonstrated that measuring central venous pressure (CVP) is significant to evaluate the ECF state in hyponatremic patients with intracranial diseases. Accordingly, it may be useful to measure the CVP in the hyponatremic patients. However, usually it is difficult to measure the CVP in all patients with hyponatremia because that the method is due to invasive procedure. With recently development, it is possible to estimate the CVP calculation using cardiac echogram without invasion. However, it is not clear that an evaluation by using such echogram estimates the state of ECF volume in hyponatremic patients.
Therefore, the investigators examine whether the CVP calculation by using cardiac echogram by Marcelino P et al. method without invasion is estimated such condition in hyponatremic patients before and after treatments.
As the primary endpoint, the VCI index values is investigated and compared with each group before and after correction of disorders of fluid with sodium. Furthermore, some variables including sodium, potassium, chloride, creatinine, BUN, uric acid, osmolality in blood and urine and plasma vasopressin are investigated and compared with each group before and after correction of disorders of fluid with sodium.
Detailed description
Calculated CVP value as VCI (vena cava inferior) index by Marcelino P et al. method-they reported that VCI index using several echocardiographic parameters measured. A transthoracic echocardiographic study was performed using an Aloka SSD 2200 echocardiograph fitted with 2.5MHz probe with continuous-wave，pulsed and color Doppler (Japan). Using pulsed Doppler，each parameter is measured as following; the deceleration rime of E wave of tricuspid inflow，the gradient between right ventricle (RV) and right atrium (RA) by continuous Doppler，the VCI variation from the corresponding maximum expiratory diameter (measured at 2 cm from the RA and in dorsal decubitus) to its diameter during inspiration. All measurements were taken at the end-expiration in order to standardize the samples. VCI index = [tricuspid E deceleration (ms)] x 0.11 + [RV/RA gradient (mmHg)] x 0.16 - [VCI variation (mm)] (VCI, vena cava inferior; tricuspid E, tricuspid E wave; RV, right ventricle, RA, right atrium).
Na, Cl, K, creatinine, BUN and uric acid in serum and urine were measured by the usual methods before and after the correction of plasma volume. Further, osmolality and vasopressin in plasma and osmolality in urine were also measured by the usual methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIADH, CSWS, CDI, PP, DIH, HF | – | Other: Calculated CVP by using cardiac echogramCSWS (cerebral salt wasting syndrome), SIADH (syndrome of inappropriate ADH) , CDI (central diabetes insipidus), PP (primary polydipsia), DIH (drug-induced hyponatremia), HF (heart failure with hyponatremia) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with disorders of fluid with sodium including cerebral salt wasting syndrome (CSWS), syndrome of inappropriate antidiuretic hormone secretion (SIADH), primary polydipsia (PP), central diabetes insipidus (CDI) and others * Patients more than 18 years old (gender is disregarded) * Healthy subjects more than 18 years old (gender is disregarded)
Key inclusion criteria (3 listed)
- Patients with disorders of fluid with sodium including cerebral salt wasting syndrome (CSWS), syndrome of inappropriate antidiuretic hormone secretion (SIADH), primary polydipsia (PP), central diabetes insipidus (CDI) and others
- Patients more than 18 years old (gender is disregarded)
- Healthy subjects more than 18 years old (gender is disregarded)
Key exclusion criteria (5 listed)
- Patients with a serious complication in the heart, liver or kidney
- Pregnant or possibly pregnant patients, or lactating patients
- Patients complicated with a malignant tumor at present.
- Patients participating in other clinical study.
- Other than the above, patients judged inappropriate as the subjects of this study by the investigator
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 |
|---|---|---|
| Calculated CVP by using cardiac echogramBefore and after the correction of plasma volume | Other | SIADH, CSWS, CDI, PP, DIH, HF |
Primary outcome
Calculated CVP by using cardiac echogram
Time frame: within the first 30 days (plus or minus 3 days) after correcting status of plasma volume
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Background: PubMed 9007863Damaraju SC, Rajshekhar V, Chandy MJ. Validation study of a central venous pressure-based protocol for the management of neurosurgical patients with hyponatremia and natriuresis. Neurosurgery. 1997 Feb;40(2):312-6; discussion 316-7. doi: 10.1097/00006123-199702000-00015.
Related trials for Other Diagnoses and Conditions
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
RecruitingObservational study
Diagnosis and Treatment of Patients With Inborn Errors of Metabolism
Arterial Calcification Due to Deficiency of CD73
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
Metastatic Breast Cancer, Metastatic Solid Cancer
RecruitingObservational study
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
Breast Cancer, Benign Breast Condition
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.
Kyuzi Kamoi, MD principal investigator
Nagaoka Red Cross Hospital and University of Niigata Prefecture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Diagnoses and Conditions, run by Nagaoka Red Cross Hospital at 1 site in Japan.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Mar 2012. 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 Japan. 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?
Results are not available in the source record.
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?
Calculated CVP by using cardiac echogram (time frame: within the first 30 days (plus or minus 3 days) after correcting status of plasma volume). 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 NCT01547650, 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 14 Mar 2012.