Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2012 | ||||
| Last Updated Date | March 13, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | February 2022 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01547650 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium | ||||
| Official Title ICMJE | Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: There is no biospeciment. |
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| 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
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| Condition ICMJE | Other Diagnoses and Conditions | ||||
| Intervention ICMJE | Other: Calculated CVP by using cardiac echogram
Before and after the correction of plasma volume |
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| Study Group/Cohort (s) | 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 |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 42 | ||||
| Estimated Completion Date | February 2023 | ||||
| Estimated Primary Completion Date | February 2022 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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
Exclusion Criteria: Patients with a serious complication in the heart, liver or kidney
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01547650 | ||||
| Other Study ID Numbers ICMJE | 3-Kamoi | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kyuzi Kamoi, Nagaoka Red Cross Hospital | ||||
| Study Sponsor ICMJE | Nagaoka Red Cross Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nagaoka Red Cross Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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