Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

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).

Study Overview

• Status: Unknown
• Conditions: Intestinal Obstruction Fluid Management With Hypertonic Saline
• Intervention / Treatment: Drug: Hypertonic saline

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasha Behery, MD; Phone Number: +201228604556; Email: rasha.behery.rz@gmail.com
• Study Contact Backup: Name: Ahmed Lotfy, MD; Phone Number: +201000608905; Email: ahmed.lotfy@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Cairo University hospitals
    • Contact: Ahmed Lotfy, MD; Phone Number: +201000608905; Email: ahmed.lotfy@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Received Hypertonic saline 3% as resuscitation fluid.	Drug: Hypertonic saline; resuscitation fluid
Active Comparator: Group B; Received Hypertonic saline 1.8% as resuscitation	Drug: Hypertonic saline; resuscitation fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume of infused fluids	the total volume of fluids given to subjects intraoperatively and postoperatively	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical complications rate	the rate of surgical complications i.e leakage and wound dehisence	4 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: N-55-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No