Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU

NCT04519762 | Unknown Phase 4

• 1 other identifier: R38/2020
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study aimed to determine the incidence of hypophosphatemia (HP) among severe sepsis/septic shock patients admitted to ICU and its impact on morbidity and mortality rates of these patients, and to evaluate the impact of phosphorous supplemental therapy (PST) on such outcomes.Thus, this study will hypothesize that diagnosis and management of HP may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU.

Conditions

Hypophosphatemia

Outcome Measures

Primary Outcomes (2)

• Mortality (No.)

  Assessment of mortality Assessment of mortality

  15 September 2020 - 15 December 2020 (3 months)

• Mortality (%)

  Assessment of mortality

  15 September 2020 - 15 December 2020 (3 months)

Study Arms (2)

Control group

SHAM COMPARATOR

Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.

Drug: Antibiotics; Drug: Inotropes

Study group

ACTIVE COMPARATOR

Management of sepsis/ septic shock in addition to management of hypophosphatemia.

Drug: Glycophos (Sodium Glycerophosphate); Drug: Antibiotics; Drug: Inotropes

Interventions

Glycophos (Sodium Glycerophosphate) DRUG

Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.

Also known as: Saline

Study group

Antibiotics DRUG

Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.

Also known as: saline

Control group; Study group

Inotropes DRUG

Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.

Also known as: saline

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with severe sepsis and/or septic shock within 24 hours of admission to ICU

You may not qualify if:

• children and adulthoods younger than 18 years
• pregnancy
• severe hemorrhagic shock
• maintenance on immunosuppressant therapy for any indication
• patients who are expected to die within the first 24 hours after admission

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Hypophosphatemia

Interventions

alpha-glycerophosphoric acid; Sodium Chloride; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ahmed Kamal, Dr.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha Hussien, Dr.

CONTACT

+201222830981; nohasayedhussien@gmail.com

Sherif Anis, Dr.

CONTACT

+2001222421674; sherifganis@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: September 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share