Stress Hydrocortisone In Pediatric Septic Shock

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

March 11, 2019

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Septic Shock
Interventions
DRUG

Hydrocortisone, sodium succinate

Patients randomized to the hydrocortisone treatment arm will receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg (maximum 50 mg) of hydrocortisone dosed every six hours for a maximum of seven days or until all vasoactive infusions have been discontinued for at least 12 hours, whichever comes first. When the hydrocortisone course is completed, the medication will be discontinued.

DRUG

Normal saline

Patients randomized to the placebo treatment arm will receive an equivalent volume of normal saline, with the identical dosing schedule to the intervention (hydrocortisone) arm.

Trial Locations (44)

17033

RECRUITING

Penn State Milton S. Hershey Children's Hospital, Hershey

19803

RECRUITING

Nemours Children's Health, Wilmington

38163

NOT_YET_RECRUITING

Le Bonheur Children's Hospital, Memphis

40202

RECRUITING

University of Louisville, Norton Children's Hospital, Louisville

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

53792

RECRUITING

University of Wisconsin Health/American Family Children's Hospital, Madison

60637

RECRUITING

University of Chicago, Comer Children's Hospital, Chicago

61603

RECRUITING

The University of Illinois at Chicago/OSF Children's Hospital of Illinois, Peoria

73104

RECRUITING

The Children's Hospital at Oklahoma University Medical Center, Oklahoma City

84108

RECRUITING

Primary Children's Hospital, Salt Lake City

85724

RECRUITING

University of Arizona Medical Centre, Tucson

90027

RECRUITING

Children's Hospital of Los Angeles, Los Angeles

92868

RECRUITING

Children's Hospital of Orange County, Orange

94143

RECRUITING

UCSF Benioff Children's Hospital - San Francisco, San Francisco

94609

RECRUITING

UCSF Benioff Children's Hospital - Oakland, Oakland

98105

RECRUITING

Seattle Children's Hospital, Seattle

02115

RECRUITING

Boston Children's Hospital, Boston

07039

RECRUITING

Saint Barnabas Medical Center, Livingston

Unknown

RECRUITING

Santa Casa de Misericordia Da Bahia, Bahia

RECRUITING

Hospital Jutta Batista - Rio de Janeiro, Rio de Janeiro

NOT_YET_RECRUITING

Rambam Health Care Campus, Haifa

NOT_YET_RECRUITING

Hadassah University Medical Center, Ein Kerem, Jerusalem

NOT_YET_RECRUITING

Schneider Children's Medical Center of Israel, Petah Tikva

RECRUITING

Kobe Children's Hospital, Kobe

RECRUITING

Aichi Children's Health and Medical Center, Nagoya

NOT_YET_RECRUITING

UKM Specialist Children's Hospital, Kuala Lumpur

RECRUITING

University Malaya Medical Centre, Kuala Lumpur

NOT_YET_RECRUITING

Sarawak General Hospital, Kuching

NOT_YET_RECRUITING

Shifa International Hospital, Islamabad

NOT_YET_RECRUITING

Aga Khan University Hospital, Karachi

RECRUITING

King Abdullah Specialist Children's Hospital, Riyadh

RECRUITING

KK Women's and Children's Hospital, Singapore

RECRUITING

Vietnam National Children's Hospital, Hanoi

NOT_YET_RECRUITING

City Children's Hospital, Ho Chi Minh City

T3B 6A8

RECRUITING

Alberta Children's Hospital, Calgary

V6H 3N1

TERMINATED

BC Children's Hospital, Vancouver

B3K 6R8

RECRUITING

IWK Health Centre, Halifax

L8N 3Z5

RECRUITING

McMaster Children's Hospital, Hamilton

N6A 5W9

RECRUITING

London Health Sciences Centre, London

K1H 8L1

RECRUITING

Children's Hospital of Eastern Ontario, Ottawa

H3T 1C5

RECRUITING

Centre hospitalier universitaire Sainte-Justine, Montreal

H4A 3J1

TERMINATED

Montreal Children's Hospital, Montreal

G1V 4G2

RECRUITING

Centre hospitalier de l'Université Laval, Québec

S7K 1M6

TERMINATED

Royal University Hospital, Saskatoon

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Canadian Critical Care Trials Group

OTHER

collaborator

Children's Hospital of Eastern Ontario

OTHER

lead

Jerry Zimmerman

OTHER