Breast CancerNCT04397419
Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction
A study testing Red Bull Energy Drink and Still water in people with Breast Cancer, run by Plastic Surgery Group AG by Prof. Jian Farhadi at 1 site in Switzerland.
Trial summary
The success rate of autologous microsurgical breast reconstruction depends on adequate intraoperative and postoperative flap perfusion. Perfusion is optimized intraoperatively by a full hyperdynamic circulation and maintenance of a normal body temperature. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Red Bull Energy Drink and Still water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 May 2020to 1 Jan 2023
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication: Patients undergoing unilateral autologous microsurgical breast reconstruction by Prof. Dr. med. Jian Farhadi, Dr. med. Alessia Lardi or Dr. med. Doris Babst
- Female participants ≥ 18 and ≤ 70 years of age
- Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form.
Who cannot join
- History of arterial hypertension*
- History of cardiac rhythm disorder*
- History of Diabetes mellitus*
- History of gastric or duodenal ulcer*
- History of hyperthyroidism or hypothyroidism*
- Current use of antihypertensive drugs, antiarrhythmic drugs, thyroid hormones (e.g. Euthyrox)*
- Allergy or intolerance to component of Red Bull® Energy Drink
- Not fulfilling inclusion criteria. * as diagnosed by the GP in the referral letter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flying High - Exploring the Effect of Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction
The success rate of autologous microsurgical breast reconstruction depends on adequate intraoperative and postoperative flap perfusion. Perfusion is optimized intraoperatively by a full hyperdynamic circulation and maintenance of a normal body temperature. Additional safe and simple postoperative measures to guarantee adequate perfusion pressure would be desirable. Recently, the effect of Red Bull® Energy Drink on cardiovascular and renal function, pain tolerance as well as performance has been studied in clinical trials involving healthy volunteers and athletes. Notably, an increase in blood pressure, heart rate, improved endothelial function and reduced pain perception have been observed. A better understanding of its effects in patients undergoing autologous microsurgical breast surgery would be of great value. When ingested in standard amounts, Red Bull® Energy Drink has been shown to be a safe beverage without notable side effects. The investigators prospectively study the effect of postoperative oral ingestion of Red Bull® Energy Drink on perfusion-related variables and patient recovery after autologous microsurgical breast reconstruction.
Read the detailed description
All consecutive female patients receiving unilateral autologous microsurgical breast reconstruction starting from quarter I 2020 will be administered a total of either 750 ml Red Bull® Energy Drink (intervention group) or 750 ml still water (control group). The first dose of 250 ml Red Bull® Energy Drink or still water will be given 2-3 hours postoperatively. The following doses will be given on postoperative day 1 for breakfast (250 ml) and for lunch (250 ml).
The systolic and diastolic blood pressure as well as pulse will be measured non-invasively using a 24-hour ambulatory blood pressure monitor at regular intervals during the first postoperative 24 hours. Total fluid administered intraoperatively and postoperatively as well as intraoperative and postoperative administration of vasoactive drugs will be recorded. Daily urinary output will be measured during 24 hours after surgery. Pain levels will be measured on Numeric Rating Scale with values ranging from 0 to 10. Rate of operative re-explorations, flap loss and total length of primary hospital stay will be recorded. Wound healing and scarring will be assessed 1 month after surgery in our clinic and documented photographically.
The variables obtained from the intervention group receiving Red Bull® Energy Drink postoperatively will be compared with the corresponding variables of patients in the control group receiving the same amount of still water.
- Conditions
- Breast Cancer
- Being tested
- Red Bull Energy Drink, Still water
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Bull Energy DrinkDietary supplement
The intervention group receives 250 ml Red Bull Energy Drink 2-3 hours after surgery and 500 ml on postoperative day 1.
Regimen:
- 2-3 hours after surgery: 250 ml
- Postoperative day 1: morning and noon (1-1-0-0) 250 ml
Still waterOther
The control group receives 250 ml still water 2-3 hours after surgery and 500 ml on postoperative day 1.
Regimen:
- 2-3 hours after surgery: 250 ml
- Postoperative day 1: morning and noon (1-1-0-0) 250 ml
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group is administered a total of 750 ml Red Bull® Energy Drink at defined time-intervals. Receives: Dietary Supplement: Red Bull Energy Drink |
| Placebo group | Placebo comparator | This group is administered a total of 750 ml still water at defined time-intervals. Receives: Other: Still water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Difference in mean systolic blood pressure [mmHg] between the intervention group and the control group at 15/30/45/60/75/90/105/120min after each of 3 Red Bull (intervention group)/water (control group) applications
Measured: Until 2 hours after last drink ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start11 May 2020
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
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 Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 intervention group, 1 placebo group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plastic Surgery Group AG by Prof. Jian Farhadi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Nicole Speck, Plastic Surgery Group AG by Prof. Jian Farhadi
- Investigators
- Jian Farhadi, M.D., Prof., Principal investigator, University of Basel, Plastic Surgery Group AG by Prof. Jian Farhadi, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397419
- Sponsor's protocol ID
- 2020-00493
- Status last verified
- Apr 2023
- First submitted
- 17 May 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Speck NE, Michalak M, Dreier K, Babst D, Lardi AM, Farhadi J. Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 May 9;12:e38487. doi: 10.2196/38487.
PubMed 37159251
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flying High - Exploring the Effect of Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04397419
- Acronym / sponsor ID
- 2020-00493
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Plastic Surgery Group AG by Prof. Jian FarhadiUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 May 2020 (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 success rate of autologous microsurgical breast reconstruction depends on adequate intraoperative and postoperative flap perfusion. Perfusion is optimized intraoperatively by a full hyperdynamic circulation and maintenance of a normal body temperature. Additional safe and simple postoperative measures to guarantee adequate perfusion pressure would be desirable. Recently, the effect of Red Bull® Energy Drink on cardiovascular and renal function, pain tolerance as well as performance has been studied in clinical trials involving healthy volunteers and athletes. Notably, an increase in blood pressure, heart rate, improved endothelial function and reduced pain perception have been observed. A better understanding of its effects in patients undergoing autologous microsurgical breast surgery would be of great value. When ingested in standard amounts, Red Bull® Energy Drink has been shown to be a safe beverage without notable side effects. The investigators prospectively study the effect of postoperative oral ingestion of Red Bull® Energy Drink on perfusion-related variables and patient recovery after autologous microsurgical breast reconstruction.
Detailed description
All consecutive female patients receiving unilateral autologous microsurgical breast reconstruction starting from quarter I 2020 will be administered a total of either 750 ml Red Bull® Energy Drink (intervention group) or 750 ml still water (control group). The first dose of 250 ml Red Bull® Energy Drink or still water will be given 2-3 hours postoperatively. The following doses will be given on postoperative day 1 for breakfast (250 ml) and for lunch (250 ml).
The systolic and diastolic blood pressure as well as pulse will be measured non-invasively using a 24-hour ambulatory blood pressure monitor at regular intervals during the first postoperative 24 hours. Total fluid administered intraoperatively and postoperatively as well as intraoperative and postoperative administration of vasoactive drugs will be recorded. Daily urinary output will be measured during 24 hours after surgery. Pain levels will be measured on Numeric Rating Scale with values ranging from 0 to 10. Rate of operative re-explorations, flap loss and total length of primary hospital stay will be recorded. Wound healing and scarring will be assessed 1 month after surgery in our clinic and documented photographically.
The variables obtained from the intervention group receiving Red Bull® Energy Drink postoperatively will be compared with the corresponding variables of patients in the control group receiving the same amount of still water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 intervention group, 1 placebo group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Red Bull Energy DrinkThis group is administered a total of 750 ml Red Bull® Energy Drink at defined time-intervals. |
| Placebo group | Placebo comparator | Other: Still waterThis group is administered a total of 750 ml still water at defined time-intervals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication: Patients undergoing unilateral autologous microsurgical breast reconstruction by Prof. Dr. med. Jian Farhadi, Dr. med. Alessia Lardi or Dr. med. Doris Babst
- Female participants ≥ 18 and ≤ 70 years of age
- Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form.
Key exclusion criteria (8 listed)
- History of arterial hypertension*
- History of cardiac rhythm disorder*
- History of Diabetes mellitus*
- History of gastric or duodenal ulcer*
- History of hyperthyroidism or hypothyroidism*
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 |
|---|---|---|
| Red Bull Energy DrinkThe intervention group receives 250 ml Red Bull Energy Drink 2-3 hours after surgery and 500 ml on postoperative day 1. Regimen: * 2-3 hours after surgery: 250 ml * Postoperative day 1: morning and noon (1-1-0-0) 250 ml | Dietary supplement | Intervention group |
| Still waterThe control group receives 250 ml still water 2-3 hours after surgery and 500 ml on postoperative day 1. Regimen: * 2-3 hours after surgery: 250 ml * Postoperative day 1: morning and noon (1-1-0-0) 250 ml | Other | Placebo group |
Primary outcome
Blood pressure
Time frame: Until 2 hours after last drink ingestion
Difference in mean systolic blood pressure [mmHg] between the intervention group and the control group at 15/30/45/60/75/90/105/120min after each of 3 Red Bull (intervention group)/water (control group) applications
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 Apr 2023.
- Derived from this study: PubMed 37159251Speck NE, Michalak M, Dreier K, Babst D, Lardi AM, Farhadi J. Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 May 9;12:e38487. doi: 10.2196/38487.
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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.
Jian Farhadi, M.D., Prof. principal investigator
University of Basel, Plastic Surgery Group AG by Prof. Jian Farhadi, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Bull Energy Drink and Still water in people with Breast Cancer, run by Plastic Surgery Group AG by Prof. Jian Farhadi at 1 site in Switzerland.
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 3 inclusion and 8 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 Apr 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Blood pressure (time frame: Until 2 hours after last drink ingestion). 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 NCT04397419, 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 25 Apr 2023.