Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
Primary Purpose
Intestinal Obstruction Fluid Management With Hypertonic Saline
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hypertonic saline
Sponsored by
About this trial
This is an interventional supportive care trial for Intestinal Obstruction Fluid Management With Hypertonic Saline
Eligibility Criteria
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.
Sites / Locations
- Cairo University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Received Hypertonic saline 3% as resuscitation fluid.
Received Hypertonic saline 1.8% as resuscitation
Outcomes
Primary Outcome Measures
Total volume of infused fluids
the total volume of fluids given to subjects intraoperatively and postoperatively
Secondary Outcome Measures
surgical complications rate
the rate of surgical complications i.e leakage and wound dehisence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03741257
Brief Title
Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
Official Title
Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Obstruction Fluid Management With Hypertonic Saline
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Received Hypertonic saline 3% as resuscitation fluid.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Received Hypertonic saline 1.8% as resuscitation
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Intervention Description
resuscitation fluid
Primary Outcome Measure Information:
Title
Total volume of infused fluids
Description
the total volume of fluids given to subjects intraoperatively and postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
surgical complications rate
Description
the rate of surgical complications i.e leakage and wound dehisence
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Behery, MD
Phone
+201228604556
Email
rasha.behery.rz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Lotfy, MD
Phone
+201000608905
Email
ahmed.lotfy@kasralainy.edu.eg
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Lotfy, MD
Phone
+201000608905
Email
ahmed.lotfy@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
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