Postoperative NauseaNCT04406506
Entral Feeding in Acute Severe Pancreatitis
An observational study of Postoperative Nausea, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea
- What is being tested?
- nasogastric, nasojejunal and (erythromycin 250 mg IV bolus)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jun 2018to 10 Apr 2020
- How long will I take part?
- 13 Days
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: * A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture. * An acute physiology and chronic health evaluation (APACHE) II were done for all of them and only score of > 8 included in our study.
Who may be able to join
- acute pancreatitis
Who cannot join
- systemic disease as hypertension or diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Different Methods of Enteral Feeding in Acute Severe Pancreatitis
- A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture.
Read the detailed description
- The study was conducted on monitoring of four pillar for 13 days (data collected one day before feeding and every three days for 12 days). the first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis and this monitored clinically and laboratory by fixed parameters, clinically, by abdominal pain which assessed by visual analogue scale (VAS). and laboratory, by both markers of severity of pancreatic acini destruction which assessed by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second pillar include effect of the two enteral feeding methods on the patient's tolerance and these monitored in our study by both post-feeding vomiting and post feeding attacks of osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral feeding methods on the patient's general condition and these monitored by follows the APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect of the two enteral feeding methods on achieving satisfactory nutrition parameters of the patients and both albumin level, radium blood sugar and electrolytes (sodium and potassium level) used as indicator for this.
- All parameters observed one day before starting feeding and every 3 days for 12 days (duration of the study).
- Conditions
- Postoperative Nausea
- Being tested
- nasogastric, nasojejunal, (erythromycin 250 mg IV bolus)
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasogastricDevice
- The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube
nasojejunalDevice
- The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
- Patients were placed in right lateral position
(erythromycin 250 mg IV bolus)Drug
prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A received nasogastric feeding (NG), insure through ngt pump Receives: Device: nasogastric; Drug: (erythromycin 250 mg IV bolus) | |
| Group B | * receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
* Patients were placed in right lateral position Receives: Device: nasojejunal; Drug: (erythromycin 250 mg IV bolus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of different methods of feeding in the clinical condition of the acute severe pancreatitis
first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis,The second pillar include effect of the two enteral feeding methods on the patient's tolerance
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start10 Jun 2018
- Primary completion2 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 13 Days
Sponsor and investigators
- Lead sponsor
- King Abdul Aziz Specialist Hospital
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406506
- Sponsor's protocol ID
- ICU-28-20
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Methods of Enteral Feeding in Acute Severe Pancreatitis
- ClinicalTrials.gov ID
- NCT04406506
- Acronym / sponsor ID
- ICU-28-20
- Conditions
- Postoperative Nausea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Abdul Aziz Specialist HospitalResearch network
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 28 May 2020 (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.
- A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture.
Detailed description
- The study was conducted on monitoring of four pillar for 13 days (data collected one day before feeding and every three days for 12 days). the first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis and this monitored clinically and laboratory by fixed parameters, clinically, by abdominal pain which assessed by visual analogue scale (VAS). and laboratory, by both markers of severity of pancreatic acini destruction which assessed by serum amylase, lipase and Markers of severity of interstitial pancreatic tissue destruction which assessed by the level of Lactate Dehydrogenase level (LDH), Aspartate aminotransferase (AST), C-reactive protein, prostacyclin and interleukin 8. The second pillar include effect of the two enteral feeding methods on the patient's tolerance and these monitored in our study by both post-feeding vomiting and post feeding attacks of osmotic diarrhea and also abdominal pain. Third pillar include effect of the two enteral feeding methods on the patient's general condition and these monitored by follows the APACHE II Score, hemodynamics of the patients in both groups (Mean arterial blood pressure and pulse) and arterial oxygen saturation (Spo2). Fourth pillar include effect of the two enteral feeding methods on achieving satisfactory nutrition parameters of the patients and both albumin level, radium blood sugar and electrolytes (sodium and potassium level) used as indicator for this.
- All parameters observed one day before starting feeding and every 3 days for 12 days (duration of the study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 13 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: nasogastric, Drug: (erythromycin 250 mg IV bolus)Group A received nasogastric feeding (NG), insure through ngt pump |
| Group B | – | Device: nasojejunal, Drug: (erythromycin 250 mg IV bolus)* receive feeding throughThe nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz. * Patients were placed in right lateral position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * A total of 60 patients admitted to King Abdulaziz Specialists Hospital between June 2018 and April 2020 with both a clinical and biochemical presentation of acute pancreatitis with the following inclusion criteria: Abdominal pain > 6 on the visual analogue scale without given analgesia , abdominal distension and tenderness with serum amylase and serum lipase at least 3 times the upper limit of the reference range (considering normal lipase level from 0-160 U/L, and normal amylase level from 0-100 U/L) with confirmed abdominal computerized axial tomography of grade D and E on Ranson and colleagues criteria(28) of inflamed pancreatic picture. * An acute physiology and chronic health evaluation (APACHE) II were done for all of them and only score of > 8 included in our study.
Key inclusion criteria (1 listed)
- acute pancreatitis
Key exclusion criteria (1 listed)
- systemic disease as hypertension or diabetes
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 |
|---|---|---|
| nasogastric• The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube | Device | Group A |
| nasojejunal* The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz. * Patients were placed in right lateral position | Device | Group B |
| (erythromycin 250 mg IV bolus)prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus | Drug | Group A, Group B |
Primary outcome
effect of different methods of feeding in the clinical condition of the acute severe pancreatitis
Time frame: 13 days
first pillar comparing the effect of the two enteral feeding methods on the clinical condition of the acute severe pancreatitis,The second pillar include effect of the two enteral feeding methods on the patient's tolerance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea, run by King Abdul Aziz Specialist Hospital at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 May 2020. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of different methods of feeding in the clinical condition of the acute severe pancreatitis (time frame: 13 days). 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 28 May 2020.