Hypertensive EpisodeHASSNCT03157661
Prevalence of Hypertensive Disease in Patients Presenting for Elective Surgery in the Western Cape, South Africa
An observational study of Hypertensive Episode, run by University of Cape Town at 7 sites in South Africa.
Trial summary
Hypertension is a major medical and public health burden throughout the world. It is estimated that 1 in 3 adult South Africans are diagnosed with hypertension, however detailed statistics reflecting the burden of disease are somewhat lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Episode
- How many people
- 382 participants
- Where
- 7 sitesSouth Africa
- Study dates
- 24 Oct 2016to 31 Oct 2016
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Study Population \& Sample Size: The study population will involve patients presenting for elective surgery, who fulfil inclusion criteria, in all surgical disciplines with elective surgical slates in the main theatre complex, during the period of the study. Inclusion Criteria: Patients included in the study will be: * > 18 years of age * Non-cardiac patients * Non-obstetric patients * Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention
Who may be able to join
- Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention
- >18 years of age
Who cannot join
- Obstetric patients
- Cardiac patients
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Africa7 sites
Groote Schuur Hospital
Cape Town, Western Cape, 7599
Mitchells Plain Hospital
Cape Town, Western Cape, 7599
Somerset Hospital
Cape Town, Western Cape, 7599
Victoria Hospital
Cape Town, Western Cape, 7599
George Hospital
George, Western Cape, 7599
Paarl Hospital
Paarl, Western Cape, 7599
Worcester Hospital
Worcester, Western Cape, 7599
About this study
Official title: A Multicentre Cross-sectional Study of the Prevalence of Hypertensive Disease in Patients Presenting for Elective Surgery in the Western Cape
Hypertension is a major medical and public health burden throughout the world. It is estimated that 1 in 3 adult South Africans are diagnosed with hypertension, however detailed statistics reflecting the burden of disease are somewhat lacking. The implications and effects of poorly controlled hypertension and its associated co-morbidities are significant and extensive. In South Africa, hypertension is the single most prevalent cardiovascular risk factor and predominant contributor to cardiovascular disease and mortality.
Read the detailed description
RESEARCH PROBLEM:
Although the diagnosis of hypertension and initiation of treatment is most frequently made in the primary health care setting, the perioperative period provides clinicians with a unique opportunity to identify patients with hypertensive disease, educate patients about the disease, and, if appropriate, initiate appropriate therapy. Furthermore it provides the opportunity to refer patients for further investigation or follow up at peripheral health care centres for ongoing management. The identification and diagnosis of hypertension as well as the effective management thereof is a primary health care target and serves as an efficient health care strategy in reducing long-term cardiovascular morbidity and mortality, as well as the burden of disease associated complications. There are however, a multitude of reasons to investigate and treat persistent hypertension in the perioperative period. The long-term end organ effects are numerous and add significantly to patient morbidity and mortality. Appropriate blood pressure control has an important long term impact on patient outcome. In the acute peri-operative setting the significance of hypertension is however less clear.
AIMS \& OBJECTIVES:
Aim of the Study:
The primary aim of the study is to identify and categorise the prevalence of hypertensive disease in adult patients presenting for non-cardiac, non-obstetric elective surgery in all surgical disciplines at 1 tertiary level institution and 6 secondary hospitals over the determined period of the study.
The secondary aims of the study will include the following 1) categorise the degree of hypertensive disease in the study population 2) identify associated target organ damage and associated risk factors 3) determine patient compliance to treatment.
In a sub-study, the primary objective will be to explore the relationship between pre-operative blood pressure measurement and intra-operative hypotension (mean arterial pressure (MAP) < 55mmHg for > 1minute as defined by Walsh et al.
In order to achieve the aims of the study the following objectives will be sought:
Objectives of the Study related to the prevalence of hypertension:
- Prevalence and degree of hypertensive disease in adult patients presenting for non-cardiac, non-obstetric, elective surgery in all surgical disciplines with elective theatre lists over the period of the study will be determined by measuring and recording preoperative blood pressure during the pre-assessment anaesthetic consultation and/or immediate preoperative period, using an automated oscillometric blood pressure measurement technique. If the blood pressure is noted to be elevated, two additional readings at least 10 minutes apart will be performed. The lowest recorded blood pressure will be used. The study will identify patients with preoperative in hospital blood pressure measurements as follows:
- SBP<140 mmHg and DBP <90 mmHg
- SBP<160 mmHg and DBP<100 mmHg
- SBP<180 mmHg and DBP<110 mmHg without end organ damage
- SBP<180 mmHg and DBP<110 mmHg with end organ damage
- Compliance to anti-hypertensive treatment will be assessed using the Morisky Medication Adherence Questionnaire.
Objectives of the sub-study related to the association of pre-operative blood pressure measurement and intra-operative hypotension:
- Any episodes of low blood pressure defined as a mean arterial pressure of less than 55mmHg will be recorded as well as the cumulative time spend below this threshold.
METHODOLOGY:
Study Design \& Data Collection:
This is a prospective quantitative study at one tertiary and six secondary level institutions involving data collected on adult, non-cardiac, non-obstetric patients presenting for elective surgery for a period of one week (from Monday at 7am to Friday at 7pm).
Data is to be collected by the anaesthesiology registrars and consultants providing anaesthetic services to elective patients, in all surgical disciplines, over the one-week period of the study.
Quantitative data will be recorded on a clinical reporting form (CRF) evaluating:
- General demographic information e.g. age, gender, ethnicity
- General medical information e.g. co-morbid conditions, risk factors for hypertension
- Presence of target organ damage which will be assessed by the presence of appropriate electrocardiographic changes, presence of impaired renal function (elevated creatinine) and/or the presence of retinopathy
- General surgical information e.g. indication for surgery and type of surgery
Study Population \& Sample Size:
The study population will involve patients presenting for elective non-cardiac, non-obstetric, surgery who are 18 years of age or older and are able to give consent. For the prevalence of hypertension and compliance to treatment part of the study, all patients regardless of the planned anaesthetic technique will be included. For the sub-study, looking at the pre-operative blood pressure and its association with intraoperative hypotension only patients who receive a general or neuraxial anaesthetic will be included. For the sub-study only, this effectively excludes patients who undergo some form of sedation or local block to facilitate their procedures e.g. cataract extraction.
Measurements:
Blood pressure measurements will be performed with an appropriately sized non-invasive blood pressure cuff, using an automated oscillometric method of blood pressure measurement.
Recruitment \& Consent:
Participants will be recruited by convenience sampling. All patients compliant with the inclusion criteria will be included in the study. Data obtained will be collected by various anaesthesiology registrars and consultants, and will not include any specific patient information, thus ensuring patient anonymity. Demographic, medical and surgical information is generally routinely available prior to anaesthetic and surgical intervention. Furthermore, blood pressure measurements are routinely performed and documented. Obtained details will be captured on a clinical reporting form and so patient records will not be altered or removed for study purposes. Finally, no additional measurements, tests or investigations will be performed which might place the patient at risk, or discomfort, or impose any additional cost or burden on patient or institutional resources.
Data Management \& Analysis:
Data capture forms will be collected and collated. The information will be captured in Excel for further statistical analysis.
Patients will be risk adjusted for:
- Duration of surgery
- Need for blood transfusion intra-operatively
- Pre-operative anaemia
- ASA status
- Functional status
- Major surgery
- Type of anaesthesia (Dependant on sample size)
ETHICAL \& LEGAL CONSIDERATIONS:
To ensure complete anonymity, no personal patient information or details will be recorded on the data collection form. As this is an audit, and the researcher will not be involved in delivery of anaesthetic care to the patients in the study, it will be the responsibility of the anaesthesiology registrars and consultants providing the anaesthetic, to ensure patient safety and well-being, at all times. This is routine, good practise and the study will not influence or detract from these patient specific clinical decisions or patient management in any way.
- Conditions
- Hypertensive Episode
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 |
|---|---|---|
| Single group study | The study population will involve patients presenting for elective surgery, who fulfil inclusion criteria, in all surgical disciplines with elective surgical slates in the main theatre complex, during the period of the study. Inclusion Criteria: Patients included in the study will be: * > 18 years of age * Non-cardiac patients * Non-obstetric patients * Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and categorisation of the prevalance of hypertensive disease in adult patients presenting for non-cardiac surgery, non-obstetric elective surgery at seven hospitals in the Western Cape, South Africa.
Prevalence and degree of hypertensive disease will be determined in adult patients presenting for non-cardiac, non-obstetric, elective surgery in all surgical disciplines with elective theatre lists over the period of the study at seven hospital in the Western Cape, South Africa. Serial preoperative blood pressure measurements will be performed in the pre-assessment anaesthetic consultation and in the immediate preoperative period, using an automated oscillometric blood pressure measurement technique.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start24 Oct 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive EpisodeStudies 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
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Marcin Nejthardt, University of Cape Town
- Investigators
- Marcin Netjhardt, MMed, Principal investigator, University of Cape TownFrancois Roodt, MMed, Study chair, University of Cape TownKaren van der Spuy, MBChB, Study chair, University of Cape TownBruce Biccard, PhD, Study chair, University of Cape TownMarcelle Crowther, MBChB, Study chair, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157661
- Sponsor's protocol ID
- Hypertension and Surgery Study
- Acronym
- HASS
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymous participant data will be collected and stored on REDCap which is a mature, secure web application for building and managing online surveys and databases. Access to individual patient information will be possible by contacting Dr MB Nejthardt at mb.nejthardt@uct.ac.za. A review of the enquiry will be undertaken by the HASS research team and the requesting person notified my email.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Cross-sectional Study of the Prevalence of Hypertensive Disease in Patients Presenting for Elective Surgery in the Western Cape
- ClinicalTrials.gov ID
- NCT03157661
- Acronym / sponsor ID
- HASS / Hypertension and Surgery Study
- Conditions
- Hypertensive Episode
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 17 May 2017 (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.
Hypertension is a major medical and public health burden throughout the world. It is estimated that 1 in 3 adult South Africans are diagnosed with hypertension, however detailed statistics reflecting the burden of disease are somewhat lacking. The implications and effects of poorly controlled hypertension and its associated co-morbidities are significant and extensive. In South Africa, hypertension is the single most prevalent cardiovascular risk factor and predominant contributor to cardiovascular disease and mortality.
Detailed description
RESEARCH PROBLEM:
Although the diagnosis of hypertension and initiation of treatment is most frequently made in the primary health care setting, the perioperative period provides clinicians with a unique opportunity to identify patients with hypertensive disease, educate patients about the disease, and, if appropriate, initiate appropriate therapy. Furthermore it provides the opportunity to refer patients for further investigation or follow up at peripheral health care centres for ongoing management. The identification and diagnosis of hypertension as well as the effective management thereof is a primary health care target and serves as an efficient health care strategy in reducing long-term cardiovascular morbidity and mortality, as well as the burden of disease associated complications. There are however, a multitude of reasons to investigate and treat persistent hypertension in the perioperative period. The long-term end organ effects are numerous and add significantly to patient morbidity and mortality. Appropriate blood pressure control has an important long term impact on patient outcome. In the acute peri-operative setting the significance of hypertension is however less clear.
AIMS \& OBJECTIVES:
Aim of the Study:
The primary aim of the study is to identify and categorise the prevalence of hypertensive disease in adult patients presenting for non-cardiac, non-obstetric elective surgery in all surgical disciplines at 1 tertiary level institution and 6 secondary hospitals over the determined period of the study.
The secondary aims of the study will include the following 1) categorise the degree of hypertensive disease in the study population 2) identify associated target organ damage and associated risk factors 3) determine patient compliance to treatment.
In a sub-study, the primary objective will be to explore the relationship between pre-operative blood pressure measurement and intra-operative hypotension (mean arterial pressure (MAP) < 55mmHg for > 1minute as defined by Walsh et al.
In order to achieve the aims of the study the following objectives will be sought:
Objectives of the Study related to the prevalence of hypertension:
- Prevalence and degree of hypertensive disease in adult patients presenting for non-cardiac, non-obstetric, elective surgery in all surgical disciplines with elective theatre lists over the period of the study will be determined by measuring and recording preoperative blood pressure during the pre-assessment anaesthetic consultation and/or immediate preoperative period, using an automated oscillometric blood pressure measurement technique. If the blood pressure is noted to be elevated, two additional readings at least 10 minutes apart will be performed. The lowest recorded blood pressure will be used. The study will identify patients with preoperative in hospital blood pressure measurements as follows:
- SBP<140 mmHg and DBP <90 mmHg
- SBP<160 mmHg and DBP<100 mmHg
- SBP<180 mmHg and DBP<110 mmHg without end organ damage
- SBP<180 mmHg and DBP<110 mmHg with end organ damage
- Compliance to anti-hypertensive treatment will be assessed using the Morisky Medication Adherence Questionnaire.
Objectives of the sub-study related to the association of pre-operative blood pressure measurement and intra-operative hypotension:
- Any episodes of low blood pressure defined as a mean arterial pressure of less than 55mmHg will be recorded as well as the cumulative time spend below this threshold.
METHODOLOGY:
Study Design \& Data Collection:
This is a prospective quantitative study at one tertiary and six secondary level institutions involving data collected on adult, non-cardiac, non-obstetric patients presenting for elective surgery for a period of one week (from Monday at 7am to Friday at 7pm).
Data is to be collected by the anaesthesiology registrars and consultants providing anaesthetic services to elective patients, in all surgical disciplines, over the one-week period of the study.
Quantitative data will be recorded on a clinical reporting form (CRF) evaluating:
- General demographic information e.g. age, gender, ethnicity
- General medical information e.g. co-morbid conditions, risk factors for hypertension
- Presence of target organ damage which will be assessed by the presence of appropriate electrocardiographic changes, presence of impaired renal function (elevated creatinine) and/or the presence of retinopathy
- General surgical information e.g. indication for surgery and type of surgery
Study Population \& Sample Size:
The study population will involve patients presenting for elective non-cardiac, non-obstetric, surgery who are 18 years of age or older and are able to give consent. For the prevalence of hypertension and compliance to treatment part of the study, all patients regardless of the planned anaesthetic technique will be included. For the sub-study, looking at the pre-operative blood pressure and its association with intraoperative hypotension only patients who receive a general or neuraxial anaesthetic will be included. For the sub-study only, this effectively excludes patients who undergo some form of sedation or local block to facilitate their procedures e.g. cataract extraction.
Measurements:
Blood pressure measurements will be performed with an appropriately sized non-invasive blood pressure cuff, using an automated oscillometric method of blood pressure measurement.
Recruitment \& Consent:
Participants will be recruited by convenience sampling. All patients compliant with the inclusion criteria will be included in the study. Data obtained will be collected by various anaesthesiology registrars and consultants, and will not include any specific patient information, thus ensuring patient anonymity. Demographic, medical and surgical information is generally routinely available prior to anaesthetic and surgical intervention. Furthermore, blood pressure measurements are routinely performed and documented. Obtained details will be captured on a clinical reporting form and so patient records will not be altered or removed for study purposes. Finally, no additional measurements, tests or investigations will be performed which might place the patient at risk, or discomfort, or impose any additional cost or burden on patient or institutional resources.
Data Management \& Analysis:
Data capture forms will be collected and collated. The information will be captured in Excel for further statistical analysis.
Patients will be risk adjusted for:
- Duration of surgery
- Need for blood transfusion intra-operatively
- Pre-operative anaemia
- ASA status
- Functional status
- Major surgery
- Type of anaesthesia (Dependant on sample size)
ETHICAL \& LEGAL CONSIDERATIONS:
To ensure complete anonymity, no personal patient information or details will be recorded on the data collection form. As this is an audit, and the researcher will not be involved in delivery of anaesthetic care to the patients in the study, it will be the responsibility of the anaesthesiology registrars and consultants providing the anaesthetic, to ensure patient safety and well-being, at all times. This is routine, good practise and the study will not influence or detract from these patient specific clinical decisions or patient management in any way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group study | – | –The study population will involve patients presenting for elective surgery, who fulfil inclusion criteria, in all surgical disciplines with elective surgical slates in the main theatre complex, during the period of the study. Inclusion Criteria: Patients included in the study will be: * > 18 years of age * Non-cardiac patients * Non-obstetric patients * Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study Population \& Sample Size: The study population will involve patients presenting for elective surgery, who fulfil inclusion criteria, in all surgical disciplines with elective surgical slates in the main theatre complex, during the period of the study. Inclusion Criteria: Patients included in the study will be: * > 18 years of age * Non-cardiac patients * Non-obstetric patients * Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention
Key inclusion criteria (2 listed)
- Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention
- >18 years of age
Key exclusion criteria (2 listed)
- Obstetric patients
- Cardiac patients
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
Identification and categorisation of the prevalance of hypertensive disease in adult patients presenting for non-cardiac surgery, non-obstetric elective surgery at seven hospitals in the Western Cape, South Africa.
Time frame: 1 Week
Prevalence and degree of hypertensive disease will be determined in adult patients presenting for non-cardiac, non-obstetric, elective surgery in all surgical disciplines with elective theatre lists over the period of the study at seven hospital in the Western Cape, South Africa. Serial preoperative blood pressure measurements will be performed in the pre-assessment anaesthetic consultation and in the immediate preoperative period, using an automated oscillometric blood pressure measurement technique.
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 31 May 2017.
- Individual participant dataSharing planned: Yes. Individual anonymous participant data will be collected and stored on REDCap which is a mature, secure web application for building and managing online surveys and databases. Access to individual patient information will be possible by contacting Dr MB Nejthardt at mb.nejthardt@uct.ac.za. A review of the enquiry will be undertaken by the HASS research team and the requesting person notified my email.
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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.
Marcin Netjhardt, MMed principal investigator
University of Cape Town
Francois Roodt, MMed study chair
University of Cape Town
Karen van der Spuy, MBChB study chair
University of Cape Town
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Episode, run by University of Cape Town at 7 sites in South Africa.
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 2 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa. 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?
Identification and categorisation of the prevalance of hypertensive disease in adult patients presenting for non-cardiac surgery, non-obstetric elective surgery at seven hospitals in the Western Cape, South Africa. (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 31 May 2017.