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Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT01547650
First received: February 23, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Other Diagnoses and Conditions
 Other: Calculated CVP by using cardiac echogram

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium

Further study details as provided by Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • Calculated CVP by using cardiac echogram [ Time Frame: within the first 30 days (plus or minus 3 days) after correcting status of plasma volume ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

There is no biospeciment.


Estimated Enrollment: 42
Study Start Date: February 2012
Estimated Study Completion Date: February 2023
Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
 Other: Calculated CVP by using cardiac echogram
Before and after the correction of plasma volume

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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)
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547650

Locations
Japan
Nagaoka Red Cross Hospital
Nagaoka, Niigata, Japan, 940-2085
Sponsors and Collaborators
Nagaoka Red Cross Hospital
Investigators
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital and University of Niigata Prefecture
  More Information

Publications:

Responsible Party: Kyuzi Kamoi, Investigator, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01547650     History of Changes
Other Study ID Numbers: 3-Kamoi
Study First Received: February 23, 2012
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on May 23, 2013