Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04519762
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Noha Sayed Hussien, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Hypophosphatemia Drug: Glycophos (Sodium Glycerophosphate) Drug: Antibiotics Drug: Inotropes Phase 4

Detailed Description:

The study will include all patients admitted to ICU with or developing severe sepsis or septic shock within 24-hr after admission to ICU. Patients will be categorized according to at-admission inorganic phosphate (Pi) level into normophosphatemia group and hypophosphatemia group (HP) (mild, moderate and severe HP). All patients will be evaluated using Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II score (APACHE II) and blood samples will be collected for ELISA estimation of serum Pi, human C-reactive protein (CRP), L-lactate, CBC picture , serum electrolytes and kidney and liver function tests. Serum Pi level will be re-estimated immediately and 24-hr after full dose administration. Outcomes will include the 28-day ICU morbidity and mortality rates and their relation to HP severity and PST administration.

Patients who will fulfill the inclusion criteria will be selectively divided into two groups according to estimated level of serum Pi: Control group will include patients with serum Pi >2.5 mg/dl and Study group will include patients having serum Pi<2.5 mg/dl and will be further sub-grouped according to severity of HP into mild HP (2-2.5 mg/dl), moderate (1-1.9 mg/dl) or severe (<1 mg/dl).

Central venous catheter will be inserted for all patients enrolled in the study via the jugular or subclavian vein. Then, baseline hemodynamic parameters and central venous pressure (CVP) will be estimated and will be continuously monitored. Arterial blood samples will be obtained anaerobically and collected in heparinized tubes for estimation of arterial blood gas and pH.

Sepsis management: Patients were managed according to guidelines of Surviving

Sepsis Campaign; briefly:

  1. Fluid therapy
  2. Vasoactive drug therapy
  3. Intropics
  4. Antibiotic therapy

HP management regimen follows:

  1. Calculation of supplementation dose according to the equation: phosphate dose (in mmol) = 0.5 x body weight x (1.25 - [serum Pi]).
  2. Preparation that will be used: Glycophos®, Fresenius Kabi Egypt (organic phosphate solution 1mmol/ml). Vial 20 ml (1ml contains 1mmol of phosphate and 2mmol of sodium).
  3. Dilution: will be diluted prior to parenteral administration. 20 ml of sodium-glycerophosphate diluted in 30 cc of dextrose 5% administered by syringe pump (50 mL).
  4. The total calculated dose will be divided into three doses every 8 hours.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Sham Comparator: Control group
Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.
Drug: Antibiotics
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Other Name: saline

Drug: Inotropes
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Other Name: saline

Active Comparator: Study group
Management of sepsis/ septic shock in addition to management of hypophosphatemia.
Drug: Glycophos (Sodium Glycerophosphate)
Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Other Name: Saline

Drug: Antibiotics
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Other Name: saline

Drug: Inotropes
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Other Name: saline




Primary Outcome Measures :
  1. Mortality (No.) [ Time Frame: 15 September 2020 - 15 December 2020 (3 months) ]
    Assessment of mortality Assessment of mortality

  2. Mortality (%) [ Time Frame: 15 September 2020 - 15 December 2020 (3 months) ]
    Assessment of mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519762


Contacts
Layout table for location contacts
Contact: Noha Hussien, Dr. +201222830981 nohasayedhussien@gmail.com
Contact: Sherif Anis, Dr. +2001222421674 sherifganis@hotmail.com

Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed Kamal, Dr. Ain Shams University
Layout table for additonal information
Responsible Party: Noha Sayed Hussien, Clinical Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT04519762    
Other Study ID Numbers: R38/2020
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypophosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Anti-Bacterial Agents
Anti-Infective Agents