Critical IllnessNCT03670771
Intraabdominal Pressure in Critically Ill Patients
An observational study of Critical Illness and Intra-Abdominal Hypertension, run by Assiut University.
Trial summary
This study is conducted to evaluate the incidence and prognostic significance of IAH in medical ICU patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Intra-Abdominal Hypertension
- What is being tested?
- Harrahill method for measuring of intraabdominal pressure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 30 Dec 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: all patients admitted to ICU due to medical cause irrespective of age or sex will be included in the study with detailed history and compelete examination will be done ,ECG will be done , SPO2 and arterial lactate concentrations and blood gases will be recorded twice daily, intraabdominal pressure wil be measured every at ltime of admission and every 6 hours until discharge or death occured.
Who may be able to join
- All patients admitted to the critical care unit of internal medicine department not listed in the exclusion criteria.
Who cannot join
- Patients diagnosed with ESRD on dialysis.
- Patients with contraindications for internal urethral catheterization as urethral injury.
- Patients who had an obvious increase in IAP as; pregnant women and obese with body mass index (BMI) > 32 kg/m2.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incidence and Prognostic Significance of Intraabdominal Pressure in Critically Ill Patients
This study is conducted to evaluate the incidence and prognostic significance of IAH in medical ICU patients.
Read the detailed description
Increased Intra-abdominal pressure (IAP) is an important cause of morbidity and mortality in ICU patients with consequent pulmonary, hepatic, central nervous and renal system impairments.
The increase in IAP is rarely diagnosed in ICU and the lack of diagnosis of this condition may lead to the worsening of patient prognoses because of retardation of appropriate interventions .
The current literatures show conflicting cutoff values of IAP that predict AKI, possibly due to the fact that many studies were conducted before publishing of the first Consensus of IAH/ACS, which standardized the measurement method of IAP.
Intra-abdominal hypertension is defined as a sustained or repeated pathologic elevation of intra-abdominal pressure greater than 12 mmHg [Malbrain et al 2004, cheathamML et al 2007]. Intra-abdominal hypertension is graded as follows:
- Grade I Intra-abdominal pressure 12-15 mmHg.
- Grade II Intra-abdominal pressure 16-20 mmHg.
- Grade III Intra-abdominal pressure 21-25 mmHg.
- Grade IV Intra-abdominal pressure greater than 25 mmHg Various risk factors contribute to the development of IAH in medical ICU including; massive fluid resuscitation (> 3500 ml/24 h), ileus, respiratory, renal, or liver dysfunction, hypothermia, acidosis, anemia, oliguria, and hyperlactatemia .
- Conditions
- Critical Illness, Intra-Abdominal Hypertension
- Being tested
- Harrahill method for measuring of intraabdominal pressure
- Medical subject headings
- Critical Illness, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harrahill method for measuring of intraabdominal pressureDiagnostic test
IAP obtained by using patient own urine as the transducing medium. One clamps the Foley catheter just above the urine collection bag. The tubing is then held at a position of 30-40 cm above the symphysis pubis and the clamp is released. The IAP is indicated by the height (in cm) of the urine column from the pubic bone. The meniscus should show respiratory variations.
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the incidence and prognostic significance of IAH in medical ICU patients.
occurance of death ,improvement or organ failure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal sayed ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670771
- Sponsor's protocol ID
- critically ill patients
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz Ferron F, Tejero Pedregosa A, Ruiz Garcia M, Ferrezuelo Mata A, Perez Valenzuela J, Quiros Barrera R, Rucabado Aguilar L. [Intraabdominal and thoracic pressure in critically ill patients with suspected intraabdominal hypertension]. Med Intensiva. 2011 Jun-Jul;35(5):274-9. doi: 10.1016/j.medin.2011.02.009. Epub 2011 Apr 15. Spanish.
PubMed 21497415
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Prognostic Significance of Intraabdominal Pressure in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03670771
- Acronym / sponsor ID
- critically ill patients
- Conditions
- Critical Illness, Intra-Abdominal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 14 Sep 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.
This study is conducted to evaluate the incidence and prognostic significance of IAH in medical ICU patients.
Detailed description
Increased Intra-abdominal pressure (IAP) is an important cause of morbidity and mortality in ICU patients with consequent pulmonary, hepatic, central nervous and renal system impairments.
The increase in IAP is rarely diagnosed in ICU and the lack of diagnosis of this condition may lead to the worsening of patient prognoses because of retardation of appropriate interventions .
The current literatures show conflicting cutoff values of IAP that predict AKI, possibly due to the fact that many studies were conducted before publishing of the first Consensus of IAH/ACS, which standardized the measurement method of IAP.
Intra-abdominal hypertension is defined as a sustained or repeated pathologic elevation of intra-abdominal pressure greater than 12 mmHg [Malbrain et al 2004, cheathamML et al 2007]. Intra-abdominal hypertension is graded as follows:
- Grade I Intra-abdominal pressure 12-15 mmHg.
- Grade II Intra-abdominal pressure 16-20 mmHg.
- Grade III Intra-abdominal pressure 21-25 mmHg.
- Grade IV Intra-abdominal pressure greater than 25 mmHg Various risk factors contribute to the development of IAH in medical ICU including; massive fluid resuscitation (> 3500 ml/24 h), ileus, respiratory, renal, or liver dysfunction, hypothermia, acidosis, anemia, oliguria, and hyperlactatemia .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients admitted to ICU due to medical cause irrespective of age or sex will be included in the study with detailed history and compelete examination will be done ,ECG will be done , SPO2 and arterial lactate concentrations and blood gases will be recorded twice daily, intraabdominal pressure wil be measured every at ltime of admission and every 6 hours until discharge or death occured.
Key inclusion criteria (1 listed)
- All patients admitted to the critical care unit of internal medicine department not listed in the exclusion criteria.
Key exclusion criteria (3 listed)
- Patients diagnosed with ESRD on dialysis.
- Patients with contraindications for internal urethral catheterization as urethral injury.
- Patients who had an obvious increase in IAP as; pregnant women and obese with body mass index (BMI) > 32 kg/m2.
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 |
|---|---|---|
| Harrahill method for measuring of intraabdominal pressureIAP obtained by using patient own urine as the transducing medium. One clamps the Foley catheter just above the urine collection bag. The tubing is then held at a position of 30-40 cm above the symphysis pubis and the clamp is released. The IAP is indicated by the height (in cm) of the urine column from the pubic bone. The meniscus should show respiratory variations. | Diagnostic test | – |
Primary outcome
evaluate the incidence and prognostic significance of IAH in medical ICU patients.
Time frame: one year
occurance of death ,improvement or organ failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Results publication: PubMed 21497415Ruiz Ferron F, Tejero Pedregosa A, Ruiz Garcia M, Ferrezuelo Mata A, Perez Valenzuela J, Quiros Barrera R, Rucabado Aguilar L. [Intraabdominal and thoracic pressure in critically ill patients with suspected intraabdominal hypertension]. Med Intensiva. 2011 Jun-Jul;35(5):274-9. doi: 10.1016/j.medin.2011.02.009. Epub 2011 Apr 15. Spanish.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Intra-Abdominal Hypertension, run by Assiut University.
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 3 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 nehal s. ahmed, specialist (00201094627608, nehalsayed181087@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the incidence and prognostic significance of IAH in medical ICU patients. (time frame: one year). 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 NCT03670771, 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 18 Sep 2018.