Variceal BleedingNCT01060267
Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial
A study testing Erythromycin in people with Variceal Bleeding, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
Trial summary
Objectives: Blood in stomach \& oesophagus in patients with variceal bleeding often obscures the endoscopic view \& makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist induces gastric emptying. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Variceal Bleeding
- What is being tested?
- Erythromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2007to Aug 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours with
- Age >18 years
- Informed consent
- Hemodynamically stable patient at the time of endoscopy after resuscitation.
Who cannot join
- Known allergy to erythromycin
- Prior gastric lavage on admission
- Current use of antiarrhythmic drugs
- Prior gastric surgery
- Previous history of cardiac arrhythmias
- Concomitant use of antihistaminic drugs with possible drug interactions with erythromycin
- Prior use of other prokinetic agents
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Bolus Infusion of Erythromycin Prior to Endoscopy in Patients Presenting With Variceal Bleeding: A Prospective, Randomized, Double- Blind ,Placebo Controlled, Trial
Objectives:
Blood in stomach \& oesophagus in patients with variceal bleeding often obscures the endoscopic view \& makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist induces gastric emptying. The aim of this study was to assess the effect of Erythromycin on endoscopic visibility and its outcome.
Read the detailed description
Methods:
Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours were randomized in a double blind trial to receive either 125 mg erythromycin or placebo 30 minutes before endoscopy. The primary end points were endoscopic visibility assessed by objective scoring system \& mean endoscopy duration. Secondary end points were need for repeat endoscopy and blood transfusions within 24 hours of first endoscopy , endoscopy related complications and length of hospital stay.
- Conditions
- Variceal Bleeding
- Being tested
- Erythromycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythromycinDrug
Also called Macrolide Antibiotic
The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
PlaceboDrug
patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin | Active comparator | The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline Receives: Drug: Erythromycin |
| Placebo Group endoscopic therapy | No intervention | Endoscopic therapy of variceal bleeding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach.
Measured: For upto 45 minutes from start to end of endoscopy
Secondary outcomes (1)
The secondary end points were; 1. the need for second look endoscopy & number of blood units transfused within 24 hours after initial endoscopy; 3. Incidence of endoscopy & drug related complications and length of hospital stay.
Measured: Five to seven days of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2007
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Variceal BleedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz Medical City
- Sponsor type
- Other government
- Investigators
- Ibrahim H Altraif, MBBS, FRCP, Principal investigator, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060267
- Sponsor's protocol ID
- RC06/019
- Status last verified
- Feb 2010
- First submitted
- 29 Dec 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8.
PubMed 21145052
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Bolus Infusion of Erythromycin Prior to Endoscopy in Patients Presenting With Variceal Bleeding: A Prospective, Randomized, Double- Blind ,Placebo Controlled, Trial
- ClinicalTrials.gov ID
- NCT01060267
- Acronym / sponsor ID
- RC06/019
- Conditions
- Variceal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- King Abdulaziz Medical CityOther government
- Study start
- Jan 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Feb 2010 (estimated)
- 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.
Objectives:
Blood in stomach \& oesophagus in patients with variceal bleeding often obscures the endoscopic view \& makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist induces gastric emptying. The aim of this study was to assess the effect of Erythromycin on endoscopic visibility and its outcome.
Detailed description
Methods:
Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours were randomized in a double blind trial to receive either 125 mg erythromycin or placebo 30 minutes before endoscopy. The primary end points were endoscopic visibility assessed by objective scoring system \& mean endoscopy duration. Secondary end points were need for repeat endoscopy and blood transfusions within 24 hours of first endoscopy , endoscopy related complications and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythromycin | Active comparator | Drug: ErythromycinThe patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline |
| Placebo Group endoscopic therapy | No intervention | Drug: PlaceboEndoscopic therapy of variceal bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours with
- Age >18 years
- Informed consent
- Hemodynamically stable patient at the time of endoscopy after resuscitation.
Key exclusion criteria (8 listed)
- Known allergy to erythromycin
- Prior gastric lavage on admission
- Current use of antiarrhythmic drugs
- Prior gastric surgery
- Previous history of cardiac arrhythmias
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 |
|---|---|---|
| ErythromycinAlso: Macrolide AntibioticThe patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline | Drug | Erythromycin |
| Placebopatients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy. | Drug | Placebo Group endoscopic therapy |
Primary outcome
The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach.
Time frame: For upto 45 minutes from start to end of endoscopy
1 secondary outcome
The secondary end points were; 1. the need for second look endoscopy & number of blood units transfused within 24 hours after initial endoscopy; 3. Incidence of endoscopy & drug related complications and length of hospital stay.
Time frame: Five to seven days of hospitalization
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 2 Feb 2010.
- Derived from this study: PubMed 21145052Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8.
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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.
Ibrahim H Altraif, MBBS, FRCP principal investigator
King Abdulaziz Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythromycin in people with Variceal Bleeding, run by King Abdulaziz Medical City 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 4 inclusion and 8 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 2 Feb 2010. 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?
The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach. (time frame: For upto 45 minutes from start to end of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060267, which also lists 1 linked publication.
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 2 Feb 2010.