Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Postoperative Complications

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection

Control patients will not be received any intervention

Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection

vitamin D

control

Zahra Vahdat Shariatpanahi, MD, PhD

Vitamin D supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.

A randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000 IU). Patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.

Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery

Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection

Complications in operating room, recovery room, ICU and neurosurgery ward

Mortality during hospitalization or 1 month after surgery

Shahid Beheshti University

Associate Professor

Heart and Blood Diseases

Head and Neck Neoplasms

Hypotension

Vascular Diseases

Central Nervous System Depressants

Antihypertensive Agents

Vasoconstrictor Agents

Anesthetics

The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring.

The HPI-group will have the HPI based monitoring with the Acumen IQ sensor (Edwards Lifesciences) and the HPI algorithm connected also to the HemoSphere platform (Edwards Lifesciences). The hemodynamic management will be based on the HPI indications and the specific algorithm, which considers hypovolemia, impaired contractility and vasodilatation. An alert pops up on the monitor screen when the HPI values exceeds 85 and then the clinician needs to make therapeutic decision in order to avoid the hypotensive episode.

Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Hypotension Prediction Index

Jakub Szrama, Ph.D.

Jakub Szrama, PhD

Agata Gradys, PhD

The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.

This prospective, randomized, controlled clinical trial will be performed in Poznan University of Medical Science Hospital. Patients fulfilling the inclusion criteria (see below) will be randomly assigned to receive invasive blood pressure monitoring + standard medical therapy (group A) or the hemodynamic monitoring with the Hypotension Prediction Index software (group B).

The studied patients will be blinded to the enrolled group.

The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery - a Pilot Study.

TWA - MAP \< 65 mmHg - time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes

time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 60 mmHg x time in minutes spent below MAP of 60 mmHg)/total duration of operation in minutes

time weighed average = (depth of hypotension in millimeters of mercury below a MAP of 55 mmHg x time in minutes spent below MAP of 55 mmHg)/total duration of operation in minutes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery	NCT03248544	Brain Neoplasms	vitamin D control	18 Years -	Shahid Beheshti University
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.	NCT05738603	Hypotension Head and Neck C... Perioperative C... Postoperative C...	Hypotension Pre...	18 Years -	Poznan University of Medical Sciences
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery	NCT03248544	Brain Neoplasms	vitamin D control	18 Years -	Shahid Beheshti University
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.	NCT05738603	Hypotension Head and Neck C... Perioperative C... Postoperative C...	Hypotension Pre...	18 Years -	Poznan University of Medical Sciences

Spots Global Cancer Trial Database for perioperative complications