A Phase 4 interventional study of Glycophos (Sodium Glycerophosphate) and Antibiotics in Hypophosphatemia, sponsored by Ain Shams University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-20.
Sponsored by Ain Shams University · Phase 4, Interventional, and Diagnostic
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.
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:
HP management regimen follows:
53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.
This study's planned enrollment of 100 is above the median of 46 across 26 interventional studies indexed under Hypophosphatemia.
Browse Hypophosphatemia studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.
Drug: Antibiotics · Drug: Inotropes
Management of sepsis/ septic shock in addition to management of hypophosphatemia.
Drug: Glycophos (Sodium Glycerophosphate) · Drug: Antibiotics · Drug: Inotropes
Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Also known as: Saline
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Also known as: saline
Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
Also known as: saline
Mortality (No.)
Assessment of mortality Assessment of mortality
Time frame: 15 September 2020 - 15 December 2020 (3 months)
Mortality (%)
Assessment of mortality
Time frame: 15 September 2020 - 15 December 2020 (3 months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2020; primary completion for Dec 2020, 3 months later.
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This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alpha-glycerophosphoric acid