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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

February 23, 2012
March 13, 2012
February 2012
February 2022   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01547650 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium
Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

There is no biospeciment.

Probability Sample

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)
Other Diagnoses and Conditions
Other: Calculated CVP by using cardiac echogram
Before and after the correction of plasma volume
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)
Intervention: Other: Calculated CVP by using cardiac echogram
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
February 2023
February 2022   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01547650
3-Kamoi
No
Kyuzi Kamoi, Nagaoka Red Cross Hospital
Nagaoka Red Cross Hospital
Not Provided
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital and University of Niigata Prefecture
Nagaoka Red Cross Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP