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NCT02084134 · OUTCOME

Number of Participants With Adrenal Insufficiency

Peri-Operative Steroid Management in Patients · Source last updated 2018-04-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 weeks following surgery

What was measured

Adrenal insufficiency was defined by a 30 or 60 min cortisol \< 18 during a cosyntropin stimulation test

Groups in this outcome

Steroid Treatment Arm

Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg hydrocortisone: 100mg at the time of surgery dexamethasone: 0.5mg every 6 hours for a total of four doses

Non-steroid Treatment

Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Steroid Treatment Arm19
Non-steroid Treatment17

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Steroid Treatment Arm2Not reportedNot reportedNot reportedNot reported
Non-steroid Treatment1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      17
    units
    Participants
description
Adrenal insufficiency was defined by a 30 or 60 min cortisol \< 18 during a cosyntropin stimulation test
groups
  1. description
    Receives intravenous hydrocortisone 100mg and following surgery intravenous dexamethasone 0.5mg hydrocortisone: 100mg at the time of surgery dexamethasone: 0.5mg every 6 hours for a total of four doses
    id
    OG000
    title
    Steroid Treatment Arm
  2. description
    Subjects will not receive any steroids at the time of surgery or after surgery unless symptoms of adrenal insufficiency develop (i.e. nausea, vomiting, dizziness, or low blood pressure).
    id
    OG001
    title
    Non-steroid Treatment
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
6 weeks following surgery
title
Number of Participants With Adrenal Insufficiency
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice