Intestinal Obstruction Fluid Management With Hypertonic Saline Clinical Trial
Official title:
Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery
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).
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | February 2020 |
| Est. primary completion date | November 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Cairo University Hospitals | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total volume of infused fluids | the total volume of fluids given to subjects intraoperatively and postoperatively | 24 hours | |
| Secondary | surgical complications rate | the rate of surgical complications i.e leakage and wound dehisence | 4 days |