CClinicalTrials.gg
Status unknownNCT03741257Updated Nov 14, 2018

Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

An interventional study of Hypertonic saline in Intestinal Obstruction Fluid Management With Hypertonic Saline, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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).

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Conditions studied

  • Intestinal Obstruction Fluid Management With Hypertonic Saline
03

In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's planned enrollment of 50 is below the median of 80 across 80 interventional studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: 20-70 years old
  • ASA≤III
  • BMI 25-40kg/m.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Group A

    Received Hypertonic saline 3% as resuscitation fluid.

    Drug: Hypertonic saline

  • Active comparator
    Group B

    Received Hypertonic saline 1.8% as resuscitation

    Drug: Hypertonic saline

Interventions

  • DrugHypertonic saline

    resuscitation fluid

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What researchers measure

Primary outcomes

  1. Total volume of infused fluids

    the total volume of fluids given to subjects intraoperatively and postoperatively

    Time frame: 24 hours

Secondary outcomes

  1. surgical complications rate

    the rate of surgical complications i.e leakage and wound dehisence

    Time frame: 4 days

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03741257
Lead sponsor
Cairo University
Responsible party
Ahmed Mohamed Lotfy (lecturer of anesthesia and intensive care, Cairo University) — Principal investigator
First posted
Nov 14, 2018
Start date
Nov 1, 2018
Primary completion
Nov 2019 (estimated)
Completion
Feb 2020 (estimated)
Last update
Nov 14, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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