Intestinal Obstruction Fluid Management With Hypertonic SalineNCT03741257
Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
A study testing Hypertonic saline in people with Intestinal Obstruction Fluid Management With Hypertonic Saline, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intestinal Obstruction Fluid Management With Hypertonic Saline
- What is being tested?
- Hypertonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-70 years old
- ASA≤III
- BMI 25-40kg/m.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo, 11562
Ahmed Lotfy, MD, +201000608905, ahmed.lotfy@kasralainy.edu.eg
About this study
Official title: 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.
Read more
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).
- Being tested
- Hypertonic saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
resuscitation fluid
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Received Hypertonic saline 3% as resuscitation fluid. Receives: Drug: Hypertonic saline |
| Group B | Active comparator | Received Hypertonic saline 1.8% as resuscitation Receives: Drug: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of infused fluids
the total volume of fluids given to subjects intraoperatively and postoperatively
Measured: 24 hours
Secondary outcomes (1)
surgical complications rate
the rate of surgical complications i.e leakage and wound dehisence
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Nov 2018
- Primary completionNov 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Obstruction Fluid Management With Hypertonic SalineStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Lotfy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741257
- Sponsor's protocol ID
- N-55-2018
- Status last verified
- Nov 2018
- First submitted
- 11 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery
- ClinicalTrials.gov ID
- NCT03741257
- Acronym / sponsor ID
- N-55-2018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Hypertonic salineReceived Hypertonic saline 3% as resuscitation fluid. |
| Group B | Active comparator | Drug: Hypertonic salineReceived Hypertonic saline 1.8% as resuscitation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20-70 years old
- ASA≤III
- BMI 25-40kg/m.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic salineresuscitation fluid | Drug | Group A, Group B |
Primary outcome
Total volume of infused fluids
Time frame: 24 hours
the total volume of fluids given to subjects intraoperatively and postoperatively
1 secondary outcome
surgical complications rate
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline in people with Intestinal Obstruction Fluid Management With Hypertonic Saline, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasha Behery, MD (+201228604556, rasha.behery.rz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of infused fluids (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.