Digestive DiseasesNCT00562445
Adrenal Insufficiency in Critical Emergencies in Digestive Diseases
An observational study of Digestive Diseases and Adrenal Insufficiency, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Digestive Diseases, Adrenal Insufficiency, Gastrointestinal Bleeding
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- May 2007to May 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to our centre that meet inclusion criteria and do not meet exclusion criteria
Who may be able to join
- Presence of acute upper gastrointestinal bleeding (variceal or peptic) + presence of hypovolemic shock (defined as a systolic blood pressure <100 mmHg coupled with a heart rate> 100 ppm), or Hb < 80 g / L;
- Acute pancreatitis (diagnosed by clinical, radiological and biochemical features)with severity criteria (At least one of the following: index of Ranson > 3, APACHE II > 8 or CPR> 120 mg/L, Balthazar CT grade E)
Who cannot join
- Age <18 years and >80 years.
- Pregnancy.
- Patient refusal to participate in the study.
- Prior corticosteroids treatment(oral or topical).
- Treatment during the 30 days prior to inclusion with any of the following drugs: contraception, etomidate, ketoconazole, rifampin or phenytoin.
- History of cranial trauma or surgery.
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- Any malignancy in treatment or progression.
- HIV infection.
- Prior known adrenal pathology.
- Patients not eligible to any active treatment because the existence of any clinical condition considered terminal.
- Patients with associated traumatic blood loss, or any other extraintestinal source of active bleeding.
- Burns.
- Patients who have been previously included in this study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
HospitalSCSP
Barcelona, Barcelona, 08025
Candid Villanueva, MD, +34620955006, cvillanueva@sanrpau.es
About this study
Official title: Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)
Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis.
This is a study using pharmaceutical specialties in the approved conditions of use.
Read the detailed description
Observational, prospective, open-label, in-patient study, that includes patients with upper gastrointestinal bleeding of variceal or peptic origin, and in patients with severe acute pancreatitis.
The adrenal function of every patient included will be evaluated in the first 24 hours of admission This assessment shall be performed using the corticotropin-stimulation short test (synacthen test), that includes serum and saliva determination of cortisol, in basal conditions and 30 and 60 minutes after the administration of 250 ug of corticotropin synthetic (Synacthen, Novartis Pharma AG, Basel, Switzerland).
The cortisol levels will be determined by competitive immunoassay using direct chemoluminescence technology (Bayer Corporation, Pittsburgh, PA, USA).
In patients with severe acute pancreatitis all of these determinations will be repeated at the third day of admission.
Several other clinical and biochemical features will be recorded.
- Conditions
- Digestive Diseases, Adrenal Insufficiency, Gastrointestinal Bleeding, Variceal Bleeding, Acute Pancreatitis
- Keywords
- Adrenal insufficiency, GI bleeding, Portal hypertension, Acute pancreatitis, Critical emergencies in digestive diseases, Severe acute pancreatitis
- Medical subject headings
- Digestive System Diseases, Adrenal Insufficiency, Gastrointestinal Hemorrhage, Pancreatitis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Peptic bleeding | |
| 2 | Portal hypertension bleeding | |
| 3 | Severe acute pancreatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative adrenal insufficiency
Measured: 1 week
Secondary outcomes (4)
Therapeutic failure
Measured: 45 days
Survival
Measured: 45 days
Variations in portal hypertension.
Measured: 7 days
Need for vasopressive drugs
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startMay 2007
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive DiseasesStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Candid Villanueva, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562445
- Sponsor's protocol ID
- ISRRA-HDA2007
- Other IDs
- EudraCT: 2007-002355-16
- Status last verified
- Nov 2007
- First submitted
- 21 Nov 2007
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence and Relevance of the Adrenal Insufficiency in Critical Emergencies in Digestive Diseases (GI Bleeding and Acute Pancreatitis)
- ClinicalTrials.gov ID
- NCT00562445
- Acronym / sponsor ID
- ISRRA-HDA2007
- Conditions
- Digestive Diseases, Adrenal Insufficiency, Gastrointestinal Bleeding, Variceal Bleeding, Acute Pancreatitis
- Keywords
- Adrenal insufficiency, GI bleeding, Portal hypertension, Acute pancreatitis, Critical emergencies in digestive diseases, Severe acute pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- May 2007
- Study completion
- May 2008 (estimated)
- First posted
- 22 Nov 2007 (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.
Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis.
This is a study using pharmaceutical specialties in the approved conditions of use.
Detailed description
Observational, prospective, open-label, in-patient study, that includes patients with upper gastrointestinal bleeding of variceal or peptic origin, and in patients with severe acute pancreatitis.
The adrenal function of every patient included will be evaluated in the first 24 hours of admission This assessment shall be performed using the corticotropin-stimulation short test (synacthen test), that includes serum and saliva determination of cortisol, in basal conditions and 30 and 60 minutes after the administration of 250 ug of corticotropin synthetic (Synacthen, Novartis Pharma AG, Basel, Switzerland).
The cortisol levels will be determined by competitive immunoassay using direct chemoluminescence technology (Bayer Corporation, Pittsburgh, PA, USA).
In patients with severe acute pancreatitis all of these determinations will be repeated at the third day of admission.
Several other clinical and biochemical features will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Peptic bleeding |
| 2 | – | –Portal hypertension bleeding |
| 3 | – | –Severe acute pancreatitis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our centre that meet inclusion criteria and do not meet exclusion criteria
Key inclusion criteria (2 listed)
- Presence of acute upper gastrointestinal bleeding (variceal or peptic) + presence of hypovolemic shock (defined as a systolic blood pressure <100 mmHg coupled with a heart rate> 100 ppm), or Hb < 80 g / L;
- Acute pancreatitis (diagnosed by clinical, radiological and biochemical features)with severity criteria (At least one of the following: index of Ranson > 3, APACHE II > 8 or CPR> 120 mg/L, Balthazar CT grade E)
Key exclusion criteria (13 listed)
- Age <18 years and >80 years.
- Pregnancy.
- Patient refusal to participate in the study.
- Prior corticosteroids treatment(oral or topical).
- Treatment during the 30 days prior to inclusion with any of the following drugs: contraception, etomidate, ketoconazole, rifampin or phenytoin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative adrenal insufficiency
Time frame: 1 week
4 secondary outcomes
Therapeutic failure
Time frame: 45 days
Survival
Time frame: 45 days
Variations in portal hypertension.
Time frame: 7 days
Need for vasopressive drugs
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
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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.
Candid Villanueva, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Digestive Diseases and Adrenal Insufficiency, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 13 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 22 Nov 2007. 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 Spain. 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 Candid Villanueva, MD (+34620955006, cvillanueva@santpau.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative adrenal insufficiency (time frame: 1 week). 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 22 Nov 2007.