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Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

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ClinicalTrials.gov Identifier: NCT03741257
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Lotfy, 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).


Condition or disease Intervention/treatment Phase
Intestinal Obstruction Fluid Management With Hypertonic Saline Drug: Hypertonic saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Total volume of infused fluids [ Time Frame: 24 hours ]
    the total volume of fluids given to subjects intraoperatively and postoperatively


Secondary Outcome Measures :
  1. surgical complications rate [ Time Frame: 4 days ]
    the rate of surgical complications i.e leakage and wound dehisence



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741257


Contacts
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Contact: Rasha Behery, MD +201228604556 rasha.behery.rz@gmail.com
Contact: Ahmed Lotfy, MD +201000608905 ahmed.lotfy@kasralainy.edu.eg

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt, 11562
Contact: Ahmed Lotfy, MD    +201000608905    ahmed.lotfy@kasralainy.edu.eg   
Sponsors and Collaborators
Cairo University

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Responsible Party: Ahmed Mohamed Lotfy, lecturer of anesthesia and intensive care, Cairo University
ClinicalTrials.gov Identifier: NCT03741257     History of Changes
Other Study ID Numbers: N-55-2018
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases