Body Composition and Serum Biochemistry After Intravenous Infusion or Oral Intake of Saline in Healthy Volunteers
Condition: Edema; Perioperative/Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

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.
    

Intervention name(s): Oral saline; Intravenous saline
Intervention type(s): Other; Other
Intervention description(s): Ingestion of 2 L of 0.9% saline solution over 1h; Infusion of 2L of 0.9% saline solution over 1h
Other intervention name(s): Sodium chloride solution; Sodium chloride solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: Saline solution; Sodium Chloride; Hypoalbuminemia; Weight Gain