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Body Composition and Serum Biochemistry After Intravenous Infusion or Oral Intake of Saline in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539798
First Posted: February 28, 2012
Last Update Posted: February 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul
  Purpose

The investigators conducted a cross-over study to compare the response of healthy young volunteers to a rapid oral intake or intravenous infusion of 0.9% saline solution on the body composition, serum electrolytes, albumin, and hematological parameters.

The investigators hypothesized that these parameters will differently adapt depending on the route of infusion


Condition Intervention
Edema Perioperative/Postoperative Complications Other: Oral saline Other: Intravenous saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Changes in Body Composition, Hematological Parameters, and Serum Biochemistry and After Rapid Intravenous Infusion or Oral Intake of 2L of 0.9% Saline Solution in Young Healthy Volunteers. A Randomized Cross-over Study

Further study details as provided by Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul:

Primary Outcome Measures:
  • Body Composition [ Time Frame: 2 hours ]
    . After having voided the bladder they were weighted to the nearest 0.1 kg and their heights were measured to the nearest 0.01 m with a estadiometer. Body mass was then calculated. Bioelectrical impedance analysis was performed with single-frequency (50 kHz) device (Bodystat 1500; Bodystat Ltd., Isle of Man, U.K.) using tetrapolar distal limb electrodes. TBW, fatty mass and lean body mass were calculated using regression equations programmed into the devices


Secondary Outcome Measures:
  • Serum electrolytes [ Time Frame: 2 hours ]
    Blood samples were collected before infusion and 1h after for laboratory assays: hematocrit, hemoglobin, blood glucose, serum electrolytes (sodium, potassium, chloride and bicarbonate), albumin, creatinine, and osmolality.


Enrollment: 10
Study Start Date: August 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Saline
Ingestion of 0.9% saline solution
Other: Oral saline
Ingestion of 2 L of 0.9% saline solution over 1h
Other Name: Sodium chloride solution
Active Comparator: Intravenous Saline
Intravenous infusion of 0.9% saline solution
Other: Intravenous saline
Infusion of 2L of 0.9% saline solution over 1h
Other Name: Sodium chloride solution

Detailed Description:

This was a cross over study including ten healthy young males (18-26 years old) with no acute or chronic illness for the last 3 months previously. They were not using any either medications or illicit drugs. Based on their body mass index (BMI) they were neither considered obese nor malnourished (BMI ranged from 22 to 27 kg/m2). They underwent the study after giving written informed consent. The study was approved by the Committee of Ethics in Research of the Julio Muller Hospital (862/CEP-HUJM/2010; Federal University of Mato Grosso, Cuiaba, Brazil). In two separate moments, all participants received in random order 2L of 0.9% saline by either the forearm vein or oral intake as follows.

Procedures The ten volunteers were fasted from midnight and they reported to the laboratory by 8-9 AM for the procedures. After having voided the bladder they were weighted to the nearest 0.1 kg and their heights were measured to the nearest 0.01 m with a estadiometer. Body mass was then calculated. Bioelectrical impedance analysis was performed with single-frequency (50 kHz) device (Bodystat 1500; Bodystat Ltd., Isle of Man, U.K.) using tetrapolar distal limb electrodes. TBW, fatty mass and lean body mass were calculated using regression equations programmed into the devices.

Firstly, a 12 gauge cannula was inserted the forearm and blood samples were collected for laboratory assays: hematocrit, hemoglobin, blood glucose, serum electrolytes (sodium, potassium, chloride and bicarbonate), albumin, creatinine, and osmolality. The volume of the urine output until 2h after the experiment was collected and measured.

Two liters of 0.9% saline were then infused over 1 hour into one of the forearm veins in all participants in supine position. An experienced anesthetist conducted the entire procedure at the laboratory. Blood pressure and pulse rate were taken every 30 minutes for 2h and the volunteers were not allowed to eat or drink during this period. After the infusion of the saline solution they were sent to void the bladder, were weighted again, and another blood sample was taken for the same assays. Another bioelectrical impedance analysis was carried out by the same manner. Two hours after the finish of the infusion they were asked to void the bladder again and the urinary output was registered.

The same volume of saline associated with a non-caloric flavor powder (Tang, Sao Paulo, Brazil) was orally ingested by the same volunteers 4 weeks after the first experiment, in the same room and following the same preparation as described. The blood samples were sent to the laboratory with a code that was broken in the end of the experiment and the data was put in a datasheet for statistical analysis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young males (18-26 years) bearing no acute or chronic illness for the last 3 months previously to the experiment

Exclusion Criteria:

  • Use of any drugs, tobacco, alcohol 2 months prior to the experiment. The investigators also planned to exclude those who for any reason do not comply with the protocols
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539798


Locations
Brazil
Hospital Universitario Julio Mullar
Cuiaba, Mato Grosso, Brazil, 78000-000
Sponsors and Collaborators
Federal University of Mato Grosso do Sul
Investigators
Principal Investigator: Jose E Aguilar-Nascimento, MD, PhD Federal University of Mato Grosso do Sul
  More Information

Responsible Party: Jose Eduardo de Aguilar-Nascimento, Full Professor, Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier: NCT01539798     History of Changes
Other Study ID Numbers: valente_crossover
Oral versus iv saline solution ( Other Grant/Funding Number: FAPEMAT- Fundação de Amparo a Pesquisa de Mato Grosso )
First Submitted: February 18, 2012
First Posted: February 28, 2012
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul:
Saline solution
Sodium Chloride
Hypoalbuminemia
Weight Gain

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Pharmaceutical Solutions