Intra-Abdominal HypertensionNCT03567265
Intra-abdominal Hypertension and Associated Factors Among Patients Admitted in Intensive Care Units in Uganda.
An observational study of Intra-Abdominal Hypertension, run by Makerere University at 1 site in Uganda.
Trial summary
The study was carried out to determine the prevalence,incidence and factors associated with intra-abdominal hypertension among patients admitted in three intensive care units in Kampala Uganda. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Intra-Abdominal Hypertension
- How many people
- 126 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2017to 28 Feb 2018
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolled critically ill patients admitted in three intensive care units in Kampala Uganda
Who may be able to join
- All patients admitted to the three intensive care units and were catheterized Patients admitted for more than 24 hours were recruited in the study Patients aged one year and above.
Who cannot join
- • Patients in which urethral catheterization was not required
- The patients that were below one year
- Patients with contraindications to intra-vesical pressure measurement including: pelvic fracture, haematuria, or neurogenic bladder.
- Pregnant women
- Patients admitted for less than 24 hours into the ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence, Incidence and Factors Associated With Intra-abdominal Hypertension Among Patients Admitted in Intensive Care Units in Uganda-a Multi Center Prospective Study
The study was carried out to determine the prevalence,incidence and factors associated with intra-abdominal hypertension among patients admitted in three intensive care units in Kampala Uganda.
It was a multi-center prospective cohort study carried out in three intensive care units where 126 patients that met the eligibility criteria were included in the study,demographics,of these were recorded and intra-abdominal pressure measured using the intra-vesical technique at 0,24,and 72 hours.data entry was done using epi-data version 3.1.Data analysis is on going.
Read the detailed description
Research Question:
What is the prevalence, incidence and associated factors of intra-abdominal hypertension among patients admitted in intensive care units in Uganda?
Rationale for research:
Intra-abdominal hypertension (IAH) is defined as intra-abdominal pressure greater than or equal to 12mmHg. In the developed world, it has been found to be common among critically ill patients and associated with high morbidity and mortality. The world society of Abdominal Compartment Syndrome recommends routine screening for IAH of all critically ill patients upon ICU admission.
Several factors have been arguably associated with intra-abdominal hypertension some of which are common among the critically ill patients in our setting. However Intra-abdominal hypertension has not been given due attention in Ugandan critical care units as evidenced by paucity of data concerning its prevalence, low levels of awareness among critical care medical staff, low levels of screening for IAH and limited routine measurement of intra-abdominal pressure among patients admitted in these units.
Intra-abdominal hypertension if undetected results in multi-organ dysfunction, increased length of ICU stay, morbidity, and mortality.
This study therefore seeks to determine the prevalence, incidence and risk factors of intra-abdominal hypertension among the critically ill in Ugandan ICUs so as to create a basis from which protocols to identify, prevent and manage it may be derived.
General objective:
To determine the incidence, prevalence and factors associated with intra-abdominal hypertension among patients admitted in intensive care units in Uganda.
Specific objectives:
To determine the baseline 24 hour and 72 hour prevalence of intra-abdominal hypertension among patients admitted in intensive care units in Uganda.
To determine the 24 hour and 72 hour incidence of intra-abdominal hypertension among patients admitted in intensive care units in Uganda.
To determine factors associated with intra-abdominal hypertension among patients admitted in the intensive care units in Uganda.
METHODS:
Research design: Multi-center prospective cohort study. This design was chosen in order to achieve better representation of patients in intensive care units in Uganda. It s a prospective study because currently there is paucity of data concerning the subject hence a retrospective analysis could not be done. Also follow up of patients is required to assess factors associated with intra-abdominal hypertension.
All patients admitted to the intensive care units will be recruited in the study. Patients' demographics will be recorded at admission. A urinary catheter shall be inserted and intra abdominal pressure measured at admission, 24 hours, and 72 hours. The patients will then be followed up for 28 day mortality.
Study population:
Sample size: 111 Subjects' state of physical health: seriously ill.
Source of participating subjects:
Mulago National Referral intensive care unit Nakasero hospital limited intensive care unit International Hospital Kampala intensive care unit.
Research procedures:
- All patients admitted in the intensive care units of the study sites during the study period shall be recruited in the study. A waiver of consent shall be obtained
- All recruited patients shall be reviewed at T0, T24, and T72 hours T0 defined as 0-3 hours post ICU admission, T24 defined as 24 hours post ICU admission, and T72 as 72 hours post ICU admission.
- During the study period, the principle investigator and /or research assistants using the data collection tool attached will collect data on day of admission, T72 hours and follow up patients for 28 day mortality.
- Data collected will include: patients 'demographics, referral source, indication for ICU admission, admission vital parameters, mode of ventilation, ventilation period, length of ICU stay, date of death/discharge from the ICU, 24 hour and cumulative fluid balance and intra-abdominal pressure measurements.
- The patients shall be catherized using a three way Foleys catheter, the urinary bladder drained and 25mls of normal saline instilled in the bladder. The tubing of the collecting bag will be clamped and the catheter connected to a saline manometer. The pressure will then be measured in centimeters of water at the end of expiration. This will be done at T0, T24 and T72 hours.
- The patients will then be followed up for 28 day ICU mortality, length of stay in the ICU, and duration of ventilation.
Risks/benefits:
Intra-abdominal pressure measurement using the intra-vesical (bladder) technique is a safe and acceptable procedure worldwide and no complications have been noted.
The intensivists in charge of the units will be notified about patients found to have intra-abdominal hypertension and they will decide the management fit for each patient.
Confidentiality assurances:
- The patients' identification will be by IP numbers and not individual names
- The data collected will be saved in multiple storage devices and stored in secure places such as drop box.
- All saved data copies will be updated on a weekly basis and resaved.
Conflict of interest:
The principle investigator has no conflict of interest.
- Conditions
- Intra-Abdominal Hypertension
- Medical subject headings
- Intra-Abdominal Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-abdominal Hypertension
Intra-abdominal pressure was measured using the intra-vesicular technique.Three measurements were done for each patient at time intervals of 0,24 and 72 hours.This was recorded in a questionnaire, the mean and maximum Intra-abdominal pressure were recorded.Intra-abdominal Hypertension was defined according to the Word Society of Abdominal Compartment Syndrome.
Measured: 6 months
Secondary outcomes (3)
To determine 28_ day ICU mortality of patients with intra-abdominal hypertension.
The patients recruited were followed up to discharge or death in the ICU.Mortality was analyzed using survival analysis method.
Measured: 6 months
To determine duration of mechanical ventilation among patients with intra-abdominal hypertension
The duration of mechanical ventilation for the patients recruited in the study was recorded in days and tabulated in form of median and inter-quartile ranges.
Measured: 6 months
To determine the length of ICU stay among patients with intra-abdominal hypertension
The period of stay of the patients recruited in the study was recorded in days on the questionnaire and tabulated in form of median and inter-quartile ranges.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Sep 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal HypertensionStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, College of Health Sciences, Makerere University
- Investigators
- Phiona Nansubuga, MBCHB, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567265
- Sponsor's protocol ID
- MREC 1254
- Other IDs
- IAH in ug
- Status last verified
- Jun 2018
- First submitted
- 26 Apr 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publication in a peer review journal
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence, Incidence and Factors Associated With Intra-abdominal Hypertension Among Patients Admitted in Intensive Care Units in Uganda-a Multi Center Prospective Study
- ClinicalTrials.gov ID
- NCT03567265
- Acronym / sponsor ID
- MREC 1254
- Conditions
- Intra-Abdominal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 25 Jun 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.
The study was carried out to determine the prevalence,incidence and factors associated with intra-abdominal hypertension among patients admitted in three intensive care units in Kampala Uganda.
It was a multi-center prospective cohort study carried out in three intensive care units where 126 patients that met the eligibility criteria were included in the study,demographics,of these were recorded and intra-abdominal pressure measured using the intra-vesical technique at 0,24,and 72 hours.data entry was done using epi-data version 3.1.Data analysis is on going.
Detailed description
Research Question:
What is the prevalence, incidence and associated factors of intra-abdominal hypertension among patients admitted in intensive care units in Uganda?
Rationale for research:
Intra-abdominal hypertension (IAH) is defined as intra-abdominal pressure greater than or equal to 12mmHg. In the developed world, it has been found to be common among critically ill patients and associated with high morbidity and mortality. The world society of Abdominal Compartment Syndrome recommends routine screening for IAH of all critically ill patients upon ICU admission.
Several factors have been arguably associated with intra-abdominal hypertension some of which are common among the critically ill patients in our setting. However Intra-abdominal hypertension has not been given due attention in Ugandan critical care units as evidenced by paucity of data concerning its prevalence, low levels of awareness among critical care medical staff, low levels of screening for IAH and limited routine measurement of intra-abdominal pressure among patients admitted in these units.
Intra-abdominal hypertension if undetected results in multi-organ dysfunction, increased length of ICU stay, morbidity, and mortality.
This study therefore seeks to determine the prevalence, incidence and risk factors of intra-abdominal hypertension among the critically ill in Ugandan ICUs so as to create a basis from which protocols to identify, prevent and manage it may be derived.
General objective:
To determine the incidence, prevalence and factors associated with intra-abdominal hypertension among patients admitted in intensive care units in Uganda.
Specific objectives:
To determine the baseline 24 hour and 72 hour prevalence of intra-abdominal hypertension among patients admitted in intensive care units in Uganda.
To determine the 24 hour and 72 hour incidence of intra-abdominal hypertension among patients admitted in intensive care units in Uganda.
To determine factors associated with intra-abdominal hypertension among patients admitted in the intensive care units in Uganda.
METHODS:
Research design: Multi-center prospective cohort study. This design was chosen in order to achieve better representation of patients in intensive care units in Uganda. It s a prospective study because currently there is paucity of data concerning the subject hence a retrospective analysis could not be done. Also follow up of patients is required to assess factors associated with intra-abdominal hypertension.
All patients admitted to the intensive care units will be recruited in the study. Patients' demographics will be recorded at admission. A urinary catheter shall be inserted and intra abdominal pressure measured at admission, 24 hours, and 72 hours. The patients will then be followed up for 28 day mortality.
Study population:
Sample size: 111 Subjects' state of physical health: seriously ill.
Source of participating subjects:
Mulago National Referral intensive care unit Nakasero hospital limited intensive care unit International Hospital Kampala intensive care unit.
Research procedures:
- All patients admitted in the intensive care units of the study sites during the study period shall be recruited in the study. A waiver of consent shall be obtained
- All recruited patients shall be reviewed at T0, T24, and T72 hours T0 defined as 0-3 hours post ICU admission, T24 defined as 24 hours post ICU admission, and T72 as 72 hours post ICU admission.
- During the study period, the principle investigator and /or research assistants using the data collection tool attached will collect data on day of admission, T72 hours and follow up patients for 28 day mortality.
- Data collected will include: patients 'demographics, referral source, indication for ICU admission, admission vital parameters, mode of ventilation, ventilation period, length of ICU stay, date of death/discharge from the ICU, 24 hour and cumulative fluid balance and intra-abdominal pressure measurements.
- The patients shall be catherized using a three way Foleys catheter, the urinary bladder drained and 25mls of normal saline instilled in the bladder. The tubing of the collecting bag will be clamped and the catheter connected to a saline manometer. The pressure will then be measured in centimeters of water at the end of expiration. This will be done at T0, T24 and T72 hours.
- The patients will then be followed up for 28 day ICU mortality, length of stay in the ICU, and duration of ventilation.
Risks/benefits:
Intra-abdominal pressure measurement using the intra-vesical (bladder) technique is a safe and acceptable procedure worldwide and no complications have been noted.
The intensivists in charge of the units will be notified about patients found to have intra-abdominal hypertension and they will decide the management fit for each patient.
Confidentiality assurances:
- The patients' identification will be by IP numbers and not individual names
- The data collected will be saved in multiple storage devices and stored in secure places such as drop box.
- All saved data copies will be updated on a weekly basis and resaved.
Conflict of interest:
The principle investigator has no conflict of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolled critically ill patients admitted in three intensive care units in Kampala Uganda
Key inclusion criteria (1 listed)
- All patients admitted to the three intensive care units and were catheterized Patients admitted for more than 24 hours were recruited in the study Patients aged one year and above.
Key exclusion criteria (5 listed)
- • Patients in which urethral catheterization was not required
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
Intra-abdominal Hypertension
Time frame: 6 months
Intra-abdominal pressure was measured using the intra-vesicular technique.Three measurements were done for each patient at time intervals of 0,24 and 72 hours.This was recorded in a questionnaire, the mean and maximum Intra-abdominal pressure were recorded.Intra-abdominal Hypertension was defined according to the Word Society of Abdominal Compartment Syndrome.
3 secondary outcomes
To determine 28_ day ICU mortality of patients with intra-abdominal hypertension.
Time frame: 6 months
To determine duration of mechanical ventilation among patients with intra-abdominal hypertension
Time frame: 6 months
To determine the length of ICU stay among patients with intra-abdominal hypertension
Time frame: 6 months
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 25 Jun 2018.
- Individual participant dataSharing planned: Undecided. publication in a peer review journal
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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.
Phiona Nansubuga, MBCHB principal investigator
Makerere University
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 Intra-Abdominal Hypertension, run by Makerere University at 1 site in Uganda.
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 5 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 25 Jun 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 Uganda. 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?
Intra-abdominal Hypertension (time frame: 6 months). 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 25 Jun 2018.