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

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ClinicalTrials.gov Identifier: NCT01539798
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul

Tracking Information
First Submitted Date  ICMJE February 18, 2012
First Posted Date  ICMJE February 28, 2012
Last Update Posted Date February 28, 2012
Study Start Date  ICMJE August 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Body Composition and Serum Biochemistry After Intravenous Infusion or Oral Intake of Saline in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary

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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE
  • Edema
  • Perioperative/Postoperative Complications
Intervention  ICMJE
  • Other: Oral saline
    Ingestion of 2 L of 0.9% saline solution over 1h
    Other Name: Sodium chloride solution
  • Other: Intravenous saline
    Infusion of 2L of 0.9% saline solution over 1h
    Other Name: Sodium chloride solution
Study Arms  ICMJE
  • Experimental: Oral Saline
    Ingestion of 0.9% saline solution
    Intervention: Other: Oral saline
  • Active Comparator: Intravenous Saline
    Intravenous infusion of 0.9% saline solution
    Intervention: Other: Intravenous saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2012)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 26 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01539798
Other Study ID Numbers  ICMJE valente_crossover
Oral versus iv saline solution ( Other Grant/Funding Number: FAPEMAT- Fundação de Amparo a Pesquisa de Mato Grosso )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso do Sul
Study Sponsor  ICMJE Federal University of Mato Grosso do Sul
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose E Aguilar-Nascimento, MD, PhD Federal University of Mato Grosso do Sul
PRS Account Federal University of Mato Grosso do Sul
Verification Date February 2012

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