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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intestinal Obstruction Fluid Management With Hypertonic Saline

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 11, 2018
Last Updated
November 13, 2018
Sponsor
Cairo University
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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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