Intestinal Obstruction Fluid Management With Hypertonic Saline
Conditions
Brief summary
Background and Rationale : Perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation. Objectives : * Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate * The incidence rate of surgical complications; infection and anastomotic dehiscence Study population & Sample size : There were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016).
Interventions
DRUGHypertonic saline
resuscitation fluid
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 20-70 years old * ASA≤III * BMI 25-40kg/m.
Exclusion criteria
* Severe CVS diseases (EF\<50%) * Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted) * Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders. * Pregnancy. * Severe chronic renal disease (s. Creatinine\> 2gm/dl or patients on dialysis). * Severe hepatic impairment (Child & Pugh classification class C). * Acid-base and electrolytes disturbances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of infused fluids | 24 hours | the total volume of fluids given to subjects intraoperatively and postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical complications rate | 4 days | the rate of surgical complications i.e leakage and wound dehisence |
Countries
Egypt
Contacts
Primary ContactRasha Behery, MD
Backup ContactAhmed Lotfy, MD
Outcome results
None listed