HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients

• Sponsor: University of Tennessee Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03710187
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

This study will be conducted as a single-center, prospective, open-label, randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus fludrocortisone is associated with a faster resolution of shock (defined as 24 hours vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill septic shock patients.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Drug: Hydrocortisone	Phase 2

Detailed Description

For three consecutive months, side 1 of the medical critical care unit (MCC1) will receive hydrocortisone alone and side 2 (MCC2) will receive the combination of hydrocortisone and fludrocortisone. After the initial three months, this will be flipped and patients admitted to MCC1 will receive the combination while patients in MCC2 will receive hydrocortisone alone for three consecutive months. This change in group assignments will occur to account for the difference in number of beds between MCC1 and MCC2, and to minimize the potential differences in patient acuity by location.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
• Actual Study Start Date: Nov 5, 2018
• Actual Primary Completion Date: Sep 27, 2019
• Actual Study Completion Date: Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h	Drug: Hydrocortisone; Hydrocortisone 50 mg IV Q6h
Active Comparator: Hydrocortisone only Hydrocortisone 50 mg IV Q6h	Drug: Hydrocortisone; Hydrocortisone 50 mg IV Q6h

Outcome Measures

Primary Outcome Measures

1. Time to Resolution of Shock [Up to one week]

   Hours for patient to achieve 24 hours vasopressor free

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay

• Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

• Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay

• Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine

• Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)

• Patients not appropriate for study inclusion as determined by provider discretion

• Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)

• Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis

• Any patient receiving greater than one dose of hydrocortisone 100 mg

• Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920

Sponsors and Collaborators

• University of Tennessee Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 27, 2018

More Information

Publications

None provided.

• Responsible Party: University of Tennessee Medical Center
• ClinicalTrials.gov Identifier: NCT03710187
• Other Study ID Numbers: UHS-CC-002
• First Posted: Oct 18, 2018
• Last Update Posted: May 20, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Shock, Septic; Shock; Hydrocortisone

Study Results

Participant Flow

Recruitment Details	Adult septic shock patients were recruited from the medical intensive care unit (MICU). Patients were recruited from November 2018 through July 2019.
Pre-assignment Detail	Patients were randomized to receive HCT 50mg IV Q6h or HCT+FCT 50 mcg PO/PT daily based on admission location within the MICU. Patients were included if age 18 or older, required stress dose steroid therapy, and received fludrocortisone within 24 hours of hydrocortisone if in the combination group.

Arm/Group Title	Combination	Hydrocortisone Only
Arm/Group Description	Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h	Hydrocortisone 50 mg IV Q6h
Period Title: Overall Study
STARTED	41	43
COMPLETED	41	43
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Combination	Hydrocortisone Only	Total
Arm/Group Description	Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h	Hydrocortisone 50 mg IV Q6h Hydrocortisone: Hydrocortisone 50 mg IV Q6h	Total of all reporting groups
Overall Participants	41	43	84
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	43 100%	84 100%
>=65 years	0 0%	0 0%	0 0%
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	43 100%	84 100%
>=65 years	0 0%	0 0%	0 0%
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	0 0%	41 48.8%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	22 53.7%	17 39.5%	39 46.4%
Male	19 46.3%	26 60.5%	45 53.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 9.8%	3 7%	7 8.3%
White	37 90.2%	40 93%	77 91.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	41 100%	43 100%	84 100%

Outcome Measures

1. Primary Outcome

Title	Time to Resolution of Shock
Description	Hours for patient to achieve 24 hours vasopressor free
Time Frame	Up to one week

Outcome Measure Data

Analysis Population Description

Adult septic shock patients admitted to the MICU. Patients were randomized to an arm of the study based on location within the MICU.

Arm/Group Title	Combination	Hydrocortisone Only
Arm/Group Description	Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h	Hydrocortisone 50 mg IV Q6h Hydrocortisone: Hydrocortisone 50 mg IV Q6h
Measure Participants	41	43
Mean (95% Confidence Interval) [Hours]	89	84

Adverse Events

Time Frame	4 months
Arm/Group Title	Combination		Hydrocortisone Only
Arm/Group Description	Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h		Hydrocortisone 50 mg IV Q6h Hydrocortisone: Hydrocortisone 50 mg IV Q6h
All Cause Mortality
	Combination		Hydrocortisone Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/43 (0%)
Serious Adverse Events
	Combination		Hydrocortisone Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Combination		Hydrocortisone Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.