Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

Not Applicable

• Conditions: Intestinal Obstruction Fluid Management With Hypertonic Saline
• Interventions: Drug: Hypertonic saline

• Registration Number: NCT03741257
• Lead Sponsor: Cairo University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-01
• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-11
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age: 20-70 years old
• ASA≤III
• BMI 25-40kg/m.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Hypertonic saline	Received Hypertonic saline 3% as resuscitation fluid.
Group B	Hypertonic saline	Received Hypertonic saline 1.8% as resuscitation

Primary Outcome Measures

Name	Time	Method
Total volume of infused fluids	24 hours	the total volume of fluids given to subjects intraoperatively and postoperatively

Secondary Outcome Measures

Name	Time	Method
surgical complications rate	4 days	the rate of surgical complications i.e leakage and wound dehisence

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt