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Prevalence of Hypertensive Disease in Patients Presenting for Elective Surgery in the Western Cape, South Africa (HASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157661
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Marcin Nejthardt, University of Cape Town

Brief 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. 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.

Condition or disease
Hypertensive Episode

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 382 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre Cross-sectional Study of the Prevalence of Hypertensive Disease in Patients Presenting for Elective Surgery in the Western Cape
Actual Study Start Date : October 24, 2016
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016


Group/Cohort
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention
  • >18 years of age

Exclusion Criteria:

  • Obstetric patients
  • Cardiac patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157661


Locations
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South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7599
Mitchells Plain Hospital
Cape Town, Western Cape, South Africa, 7599
Somerset Hospital
Cape Town, Western Cape, South Africa, 7599
Victoria Hospital
Cape Town, Western Cape, South Africa, 7599
George Hospital
George, Western Cape, South Africa, 7599
Paarl Hospital
Paarl, Western Cape, South Africa, 7599
Worcester Hospital
Worcester, Western Cape, South Africa, 7599
Sponsors and Collaborators
University of Cape Town
Investigators
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Principal Investigator: Marcin Netjhardt, MMed University of Cape Town
Study Chair: Francois Roodt, MMed University of Cape Town
Study Chair: Karen van der Spuy, MBChB University of Cape Town
Study Chair: Bruce Biccard, PhD University of Cape Town
Study Chair: Marcelle Crowther, MBChB University of Cape Town
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Responsible Party: Dr Marcin Nejthardt, Dr Marcin Nejhardt, University of Cape Town
ClinicalTrials.gov Identifier: NCT03157661    
Other Study ID Numbers: Hypertension and Surgery Study
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases