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

Other Diagnoses and Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01547650
• Other study ID #: 3-Kamoi
• Status: Active, not recruiting
• Phase: N/A
• First received: February 23, 2012
• Last updated: March 13, 2012
• Start date: February 2012
• Est. completion date: February 2023

Study information

• Verified date: March 2012
• Source: Nagaoka Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: February 2023
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Other Diagnoses and Conditions

Intervention

Other:
• Calculated CVP by using cardiac echogram
Before and after the correction of plasma volume

Locations

Country	Name	City	State
Japan	Nagaoka Red Cross Hospital	Nagaoka	Niigata

Sponsors (1)

Lead Sponsor	Collaborator
Nagaoka Red Cross Hospital

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated CVP by using cardiac echogram		within the first 30 days (plus or minus 3 days) after correcting status of plasma volume	Yes