Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

November 13, 2018 updated by: Ahmed Mohamed Lotfy, Cairo University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24 hours
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
Time Frame: 4 days
the rate of surgical complications i.e leakage and wound dehisence
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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