NCT04397419

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

May 17, 2020

Last Update Submit

April 23, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    Until 2 hours after last drink ingestion

Study Arms (2)

Intervention group

EXPERIMENTAL

This group is administered a total of 750 ml Red Bull® Energy Drink at defined time-intervals.

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.

Other: Still water

Interventions

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

Intervention group
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

Placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Pyramide am See

Zurich, Canton of Zurich, 8034, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37159251DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jian Farhadi, M.D., Prof.

    University of Basel, Plastic Surgery Group AG by Prof. Jian Farhadi, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1 intervention group, 1 placebo group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Jian Farhadi

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 21, 2020

Study Start

May 11, 2020

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CH(1)