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

Hemodynamic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803330
• Other study ID #: 202303-1
• Status: Completed
• Phase: N/A
• Start date: February 20, 2014
• Est. completion date: October 20, 2022

Study information

• Verified date: March 2023
• Source: Handan First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets Exclusion Criteria: Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma

Related Conditions & MeSH terms

• Hemodynamic
• Pheochromocytoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kunwu Yan,MM

References & Publications (4)

Bihain F, Nomine-Criqui C, Guerci P, Gasman S, Klein M, Brunaud L. Management of Patients with Treatment of Pheochromocytoma: A Critical Appraisal. Cancers (Basel). 2022 Aug 9;14(16):3845. doi: 10.3390/cancers14163845. — View Citation

Challis BG, Casey RT, Simpson HL, Gurnell M. Is there an optimal preoperative management strategy for phaeochromocytoma/paraganglioma? Clin Endocrinol (Oxf). 2017 Feb;86(2):163-167. doi: 10.1111/cen.13252. Epub 2016 Oct 24. — View Citation

Meijs AC, Snel M, Corssmit EPM. Pheochromocytoma/paraganglioma crisis: case series from a tertiary referral center for pheochromocytomas and paragangliomas. Hormones (Athens). 2021 Jun;20(2):395-403. doi: 10.1007/s42000-021-00274-6. Epub 2021 Feb 11. — View Citation

Randle RW, Balentine CJ, Pitt SC, Schneider DF, Sippel RS. Selective Versus Non-selective alpha-Blockade Prior to Laparoscopic Adrenalectomy for Pheochromocytoma. Ann Surg Oncol. 2017 Jan;24(1):244-250. doi: 10.1245/s10434-016-5514-7. Epub 2016 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative mean arterial pressure	an intraoperative mean arterial pressure <60 mmHg is considered to be hemodynamically unstable	During surgery