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

NCT01547650 | Unknown

• 1 other identifier: 3-Kamoi
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Other Diagnoses and Conditions

Outcome Measures

Primary Outcomes (1)

• Calculated CVP by using cardiac echogram

  within the first 30 days (plus or minus 3 days) after correcting status of plasma volume

Study Arms (1)

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

Interventions

Calculated CVP by using cardiac echogram OTHER

Before and after the correction of plasma volume

SIADH, CSWS, CDI, PP, DIH, HF

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nagaoka Red Cross Hospital: lead

Study Sites (1)

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2085, Japan

Location

Related 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. doi: 10.1097/00006123-199702000-00015.

  PMID: 9007863 BACKGROUND

Biospecimen

Retention: NONE RETAINED

There is no biospeciment.

Study Officials

• Kyuzi Kamoi, MD

  Nagaoka Red Cross Hospital and University of Niigata Prefecture

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 8, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

JP (1)