Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma

March 25, 2023 updated by: Kunwu Yan,MM

Clinical Study of Abandonment of Intravenous Volume Expansion After Preoperative Use of α-blockers in Patients With Adrenal Pheochromocytoma

Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients were subclassified into either the hemodynamic stability group (HS group) or the hemodynamic instability group (HU group) according to whether intraoperative hemodynamic instability occurred. Differences in data between the two groups were examined, and the risk factors for intraoperative hemodynamic instability were analyzed using logistic regression.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets

Exclusion Criteria:

Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: PXB combined with venous dilation group
Use of PXB combined with intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
Experimental: PXB group
PXB alone during preoperative preparation in patients with pheochromocytoma
Drug: Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
Abandonment of intravenous volume expansion with alpha-blockers during preoperative preparation in patients with pheochromocytoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative mean arterial pressure
Time Frame: During surgery
an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kunwu Yan,MM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2014

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 25, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202303-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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