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

Sponsor

Kunwu Yan,MM (Other)

Overall Status

Completed

CT.gov ID

NCT05803330

Collaborator

(none)

Enrollment

Arms

104

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adrenal Pheochromocytoma Hemodynamic	Drug: Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 20, 2014

Actual Primary Completion Date :

Oct 20, 2022

Actual Study Completion Date :

Oct 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

intraoperative mean arterial pressure [During surgery]
an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets

Exclusion Criteria:

Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kunwu Yan,MM

Investigators

Principal Investigator: kunwu yan, Master, Handan First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kunwu Yan,MM, Research Project Leader, Handan First Hospital

ClinicalTrials.gov Identifier:

NCT05803330

Other Study ID Numbers:

202303-1

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pheochromocytoma

Study Results

No Results Posted as of Apr 7, 2023