Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT (PHOS-CRRT)

A Randomized, Double-Blind, Parallel-Controlled, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Phosphate-Containing Replacement Fluid in Continuous Renal Replacement Therapy

Brief Summary: Evaluating a New Phosphate-Containing Fluid for Blood Purification (CRRT) Why is this study being done? Patients in the Intensive Care Unit (ICU) often need a treatment called Continuous Renal Replacement Therapy (CRRT). This is a type of blood purification that acts like an artificial kidney to clear toxins and extra fluid from the body.

A common problem during this treatment is that vital minerals, like phosphate, are washed out of the blood along with the toxins. Low phosphate can lead to muscle weakness and breathing problems. Currently, doctors must manually add phosphate to the treatment fluids, which can be inconsistent. This study aims to test a new, pre-mixed fluid that already contains phosphate to see if it works better and is safe.

What are the main questions the study aims to answer?

Does the new fluid help keep phosphate at a healthy level in the blood during the first 72 hours of treatment?

How does the new fluid affect kidney function compared to the standard fluid?

Is the new fluid safe for patients to use?

Who can take part in this study?

The study is looking for adults (18 and older) who:

Are in the ICU and need CRRT treatment as decided by their doctor.

Are expected to need this treatment for at least 72 hours.

Are willing to participate (or have a legal guardian who agrees).

People who are pregnant, have known allergies to the fluid ingredients, or have very low blood pressure that cannot be corrected may not be able to join.

How will the research happen? This is a "double-blind" study involving 220 participants across 15 hospitals. This means neither the patients nor the doctors will know which fluid is being used until the study is over.

Participants will be put into one of two groups by a computer:

Group 1 (New Fluid): Receives the blood purification fluid that has phosphate already in it.

Group 2 (Standard Fluid): Receives the standard fluid that does not have phosphate.

What will participants have to do?

Receive Treatment: Participants will receive their assigned fluid during their normal CRRT care for up to 7 days.

Blood Tests: Doctors will take regular blood samples to check mineral levels and kidney health.

Monitoring: The medical team will closely watch participants for any side effects or safety concerns.

Follow-up: There will be a safety check-up 7 days after the treatment ends.

Possible Benefits and Risks The new fluid may help prevent low phosphate levels, which could help with recovery. However, as with any medical treatment, there is a risk of side effects or electrolyte imbalances. The research team will monitor every participant 24/7 to ensure their safety.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Acute Kidney Injury; Critically Ill Patients Requiring Continuous Renal Replacement Therapy
• Intervention / Treatment: Drug: Phosphate-containing Replacement Fluid; Drug: Standard Phosphate-free Replacement Fluid

Detailed Description

Scientific Rationale and Study Objective:

Continuous renal replacement therapy (CRRT) is a standard life-support intervention in the ICU. However, standard phosphate-free replacement fluids frequently lead to unintended phosphorus removal, causing treatment-induced hypophosphatemia. This electrolyte imbalance is clinically significant, as it is linked to impaired muscle function and delayed respiratory weaning. This Phase III trial evaluates a novel, pre-mixed, phosphate-containing replacement fluid designed to maintain physiological phosphorus homeostasis and provide high-quality evidence for its standardized use in preventing CRRT-induced complications.

Study Design and Multicenter Implementation:

This is a randomized, double-blind, parallel-controlled trial conducted across 15 tertiary medical centers in China. A total of 220 participants requiring ≥ 72 hours of CRRT will be randomized 1:1 via a central Interactive Web Response System (IWRS). The study utilizes a dual-primary endpoint framework to demonstrate that the phosphate-containing fluid is non-inferior to standard therapy in renal replacement efficacy (creatinine clearance) and superior in preventing hypophosphatemia (serum phosphorus < 0.81 mmol/L). All sites follow a standardized CRRT protocol, including unified blood flow rates and effluent dosing, to minimize confounding variables.

Blinding and Intervention Protocol:

To ensure the integrity of the double-blind design, the experimental phosphate-containing fluid and the control fluid are identical in appearance, labeling, and packaging. The intervention lasts for a maximum of 7 days, followed by a 7-day post-treatment follow-up. Clinical monitoring includes regular assessments of vital signs, fluid balance, and blood gas analysis. Secondary outcomes focus on organ function (SOFA scores), mechanical ventilation duration, and comprehensive metabolic stability, including glycemic and electrolyte balance.

Data Management and Quality Assurance:

Data integrity is managed through an Electronic Data Capture (EDC) system with rigorous Source Data Verification (SDV) at all 15 sites to ensure compliance with Good Clinical Practice (GCP). An independent Data Monitoring Committee (DMC) is established to periodically review safety data and protect participant welfare, ensuring the scientific rigor and safety of this multicenter clinical investigation.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianfeng Wu, MD PhD; Phone Number: +86-20-87755766 ext 8454; Email: wujianf@mail.sysu.edu.cn
• Study Contact Backup: Name: Chuanxi Chen, MD PhD; Phone Number: +86-20-87755766 ext 8454; Email: chenchx23@mail.sysu.edu.cn

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Fachun Zhou; Phone Number: 8623-88955818; Email: zhoufachun@hospital.cqmu.edu.cn
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
      • Contact: Xiangdong Guan; Phone Number: 8620-87755766; Email: guanxd@mail.sysu.edu.cn
      • Principal Investigator: Wei Chen, MD, PhD
      • Principal Investigator: Xiangdong Guan, MD, PhD
    • Guangzhou, Guangdong, China
      • Nanfang Hospital, Southern Medical University
      • Contact: Zhongqing Chen; Phone Number: 86-13503049103; Email: 13503049103@163.com
    • Guangzhou, Guangdong, China
      • Zhujiang Hospital, Southern Medical University
      • Contact: Zhanguo Liu; Phone Number: 8620-62782020; Email: zhguoliu@163.com
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital, Sun Yat-Sen Unive
      • Contact: Benquan Wu; Phone Number: 8620-85253333; Email: zswbq@163.com
  • Guangxi
    • Nanning, Guangxi, China
      • The People's Hospital Of Guangxi Zhuang Autonomous Region
      • Contact: Shulin Xiang; Phone Number: 86771-2803237; Email: xiangshulin27@163.com
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan University of Science & Technology
      • Contact: Junxia Wang; Phone Number: 86-18638859997; Email: lyyzwjx@126.com
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Zhanzheng Zhao; Phone Number: 86-13938525666; Email: 13938525666@139.com
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Contact: You Shang; Phone Number: 86-15972127819; Email: you_shanghust@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital
      • Contact: Huijuan Mao; Phone Number: 8625-52271000; Email: maohuijuan72@njmu.edu.cn
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi 'An Jiaotong University
      • Contact: Qindong Shi; Phone Number: 8629-85323200; Email: shiqindong@163.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Renji Hospital, Shanghai Jiao Tong University
      • Contact: Yuan Gao; Phone Number: 8621-58752345; Email: gaoyuanzhuren@126.com
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Provincial People's Hospital
      • Contact: Xiaoshuang Zhou; Phone Number: 86351-4960081; Email: zhouxiaoshuang@sxmu.edu.cn
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
      • Contact: Ping Fu; Phone Number: 8628-85422114; Email: fupinghx@scu.edu.cn
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
      • Contact: Xiaobo Huang; Phone Number: 8628-87393999; Email: drhuangxb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must meet all of the following criteria to be eligible for the study:

  1. Aged 18 years or older, regardless of gender.
  2. Meet the clinical indications for Continuous Renal Replacement Therapy (CRRT) as defined by the "Standard Operating Procedures for Blood Purification (2021 Edition)" and assessed by a qualified nephrologist or intensive care physician.
  3. Expected continuous blood purification duration is 72 hours or longer.
  4. The participant or their legal guardian has a full understanding of the purpose and significance of the trial, voluntarily agrees to participate and comply with the study procedures, and has signed the written Informed Consent Form (ICF).

Exclusion Criteria:

• Participants meeting any of the following criteria will be excluded from the study:

  1. Known allergy to any component of the investigational drug, or individuals with an allergic constitution.
  2. Inability to establish suitable vascular access for CRRT.
  3. Persistent hypotension (Systolic Blood Pressure < 90 mmHg or Mean Arterial Pressure < 65 mmHg) that is difficult to correct, unless judged by the investigator as potentially correctable with intervention.
  4. Presence of malignant tumors with systemic metastasis (except for those who previously underwent radical surgery without recurrence).
  5. Pregnant or breastfeeding women.
  6. Receipt of any form of renal replacement therapy (RRT) or blood purification treatment within 24 hours prior to screening.
  7. Receipt of peritoneal dialysis within 24 hours prior to screening.
  8. Participation in any other clinical trial involving investigational drugs or devices within 1 month prior to screening.
  9. Any other condition or reason that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group: Phosphate-containing Replacement Fluid; Participants in this arm will receive the phosphate-containing replacement fluid during Continuous Renal Replacement Therapy (CRRT). The solution is a premixed, electrolyte-balanced fluid containing phosphorus (as phosphate ions). Administration: Delivered via the replacement fluid port of the CRRT machine. Dose/Flow Rate: Standardized according to the study protocol (e.g., 25-35 mL/kg/h) to maintain hemodynamic stability and solute clearance. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT.	Drug: Phosphate-containing Replacement Fluid; Phosphate-containing Replacement Fluid is an investigational Class 2.3 modified chemical drug approved by the NMPA (No. 2021LP00824). It is a premixed, electrolyte-balanced replacement fluid containing phosphorus. The solution is administered via the extracorporeal circuit during Continuous Renal Replacement Therapy (CRRT). The dosage and flow rate are standardized according to the subject's body weight and clinical requirements (typically 25-35 mL/kg/h).
Sham Comparator: Control Group: Standard Phosphate-free Replacement Fluid; Participants in this arm will receive a standard phosphate-free replacement fluid (Basal replacement solution) during Continuous Renal Replacement Therapy (CRRT). This solution contains standard electrolytes (Sodium, Potassium, Calcium, Magnesium, Chloride) and bicarbonate but lacks phosphate. Administration: Delivered via the replacement fluid port using the same CRRT equipment and settings as the experimental group. Dose/Flow Rate: Managed identically to the experimental group to ensure a comparable dialysis dose. Duration: Expected intervention duration is 72 hours, with a maximum treatment period of up to 7 days, or until clinical termination of CRRT.	Drug: Standard Phosphate-free Replacement Fluid; A marketed phosphate-free replacement fluid (standard of care). Administration via extracorporeal circuit with doses identical to the experimental group. Treatment is expected for 72 hours, up to a maximum of 7 days, or until CRRT is clinically terminated. This comparator evaluates the efficacy of the phosphate-containing solution in preventing treatment-induced hypophosphatemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Creatinine at 72 Hours	Percentage change in serum creatinine from baseline to 72 hours to evaluate the non-inferiority of the phosphate-containing fluid in solute clearance.	72 hours
Incidence of Hypophosphatemia Within 72 Hours	Percentage of participants with any measured serum phosphorus < 0.81 mmol/L during the 72-hour treatment window.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Serum Creatinine	The relative change in serum creatinine concentration compared to the baseline value. It is calculated as: [(Value at post-treatment visit - Baseline Value) / Baseline Value] x 100%.	Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 12-24 hours thereafter until the end of treatment (up to 7 days).
Sequential Organ Failure Assessment (SOFA) Score	The Sequential Organ Failure Assessment (SOFA) score is used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. The total score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.	Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Total Amount of Exogenous Phosphorus Supplementation	The cumulative amount of exogenous phosphorus administered to participants to maintain serum phosphate levels within the target range.	Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Exogenous Phosphorus Supplementation	The percentage of participants who required exogenous phosphorus supplementation during the CRRT procedure to maintain serum phosphorus levels within the target range. This measure evaluates the clinical demand for phosphorus replacement in both groups.	Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Change From Baseline in Serum Phosphorus Levels	The absolute change in serum phosphorus concentrations measured at each specified time point relative to the baseline value. This measure evaluates the stability of phosphate homeostasis during the CRRT procedure.	Baseline, 24 hours, 48 hours, and 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Duration of Mechanical Ventilation During the Treatment Period	The cumulative number of hours the participant requires mechanical ventilation (including invasive and non-invasive). The measurement period starts from the initiation of CRRT and continues until 7 days after the cessation of CRRT treatment.	From the initiation of CRRT through 7 days after the completion of CRRT treatment.
Incidence of Hypophosphatemia (Excluding the 72-hour Primary Endpoint)	The percentage of participants who develop hypophosphatemia, defined as serum phosphorus levels below 0.81 mmol/L. This measure specifically tracks the occurrence within the first 24 hours, 48 hours, and throughout the entire treatment course to assess the early and overall safety profile, distinct from the primary endpoint assessed at 72 hours.	Within 24 hours, 48 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Duration of Hypophosphatemia	The cumulative duration (in hours) during which the participant's serum phosphorus level is below 0.81 mmol/L. The duration is calculated based on serial measurements: every 6 hours during the first 72 hours, and every 12 hours thereafter until the end of the treatment period.	Within the first 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Hyperphosphatemia	The percentage of participants who develop hyperphosphatemia, defined as a serum phosphorus level above 1.45 mmol/L (or according to the institutional standard), at any time during the specified intervals.	Within the first 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Duration of Hyperphosphatemia	The cumulative duration (in hours) during which the participant's serum phosphorus level is above 1.45 mmol/L. The duration is calculated based on serial measurements: every 6 hours during the first 72 hours, and every 12 hours thereafter until the end of the treatment period.	Within 24 hours, 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Recovery Rate of Hyperphosphatemia	The percentage of participants with baseline hyperphosphatemia (serum phosphorus > 1.45 mmol/L) who achieve and maintain normal serum phosphorus levels (≤ 1.45 mmol/L) during specified intervals. Recovery is defined as phosphorus levels remaining ≤ 1.45 mmol/L consistently from 24 to 48 hours, 48 to 72 hours, and from 72 hours until the end of the treatment period (if treatment exceeds 72 hours).	24 to 48 hours, 48 to 72 hours, and from 72 hours until the end of the treatment period (if treatment exceeds 72 hours).
Proportion of Participants With Normal Serum Phosphorus Levels	The percentage of participants whose serum phosphorus levels are within the normal range, defined as ≤ 1.45 mmol/L and ≥ 0.81 mmol/L. This measure is assessed once daily through laboratory monitoring.	At 48 hours, 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Incidence of Hyperglycemia	The percentage of participants with baseline blood glucose < 10 mmol/L who develop hyperglycemia (defined as blood glucose ≥ 10 mmol/L) at any point during the specified time intervals. This measure evaluates the impact of the intervention on glycemic control.	Within 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Hypoglycemia	The percentage of participants with baseline blood glucose ≥ 3.9 mmol/L who develop hypoglycemia (defined as blood glucose < 3.9 mmol/L) at any point during the specified time intervals. This measure is used to evaluate the metabolic safety of the intervention.	Within 48 hours, 72 hours, and during the entire treatment period (up to 7 days) after CRRT initiation.
Incidence of Electrolyte and Acid-Base Deviations	The percentage of participants with electrolyte and acid-base values outside the clinical reference ranges for Sodium (Na+), Calcium (Ca2+), Magnesium (Mg2+), Chloride (Cl-), Bicarbonate (HCO3-), and pH. Deviations will be analyzed and reported separately as the proportion of participants with values below the lower limit of normal (LLN) and the proportion with values above the upper limit of normal (ULN) at each specified time point.	Baseline, 24 hours, 48 hours, 72 hours after CRRT initiation, and every 24 hours thereafter until the end of treatment (up to 7 days).
Incidence of Adverse Events	Percentage of participants experiencing at least one adverse event (AE). An AE is defined as any untoward medical occurrence, including worsening of pre-existing conditions, new clinical symptoms, signs, or clinically significant laboratory abnormalities, regardless of causal relationship with the study drug. Note: Expected disease progression related to CRRT indications or comorbidities is not considered an AE unless it results in death or is more severe than expected. Notably, hypophosphatemia and hyperphosphatemia are reported separately and are NOT counted as AEs in this study.	From the initiation of CRRT through 7 days after the completion of CRRT treatment.
Incidence of Clinically Significant Abnormalities During the Treatment Period	The percentage of participants experiencing at least one clinically significant abnormal change in vital signs, 12-lead electrocardiograms (ECG), or laboratory parameters. "During the treatment period" is defined as the interval from the initiation of Continuous Renal Replacement Therapy (CRRT) until the cessation of the treatment.	From the initiation of CRRT until the end of CRRT treatment (up to 7 days).

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Publications and helpful links

General Publications

• Demirjian S, Teo BW, Guzman JA, Heyka RJ, Paganini EP, Fissell WH, Schold JD, Schreiber MJ. Hypophosphatemia during continuous hemodialysis is associated with prolonged respiratory failure in patients with acute kidney injury. Nephrol Dial Transplant. 2011 Nov;26(11):3508-14. doi: 10.1093/ndt/gfr075. Epub 2011 Mar 7.
• Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.
• Crowley KE, DeGrado JR, Charytan DM. Serum glucose and phosphorus concentrations during continuous renal replacement therapy using commercial replacement solutions with or without phosphorus. Hemodial Int. 2020 Jul;24(3):330-334. doi: 10.1111/hdi.12834. Epub 2020 Apr 29.
• Broman M, Carlsson O, Friberg H, Wieslander A, Godaly G. Phosphate-containing dialysis solution prevents hypophosphatemia during continuous renal replacement therapy. Acta Anaesthesiol Scand. 2011 Jan;55(1):39-45. doi: 10.1111/j.1399-6576.2010.02338.x. Epub 2010 Oct 29.
• Godaly G, Carlsson O, Broman M. Phoxilium((R)) reduces hypophosphataemia and magnesium supplementation during continuous renal replacement therapy. Clin Kidney J. 2016 Apr;9(2):205-10. doi: 10.1093/ckj/sfv133. Epub 2015 Dec 19.
• Pistolesi V, Zeppilli L, Fiaccadori E, Regolisti G, Tritapepe L, Morabito S. Hypophosphatemia in critically ill patients with acute kidney injury on renal replacement therapies. J Nephrol. 2019 Dec;32(6):895-908. doi: 10.1007/s40620-019-00648-5. Epub 2019 Sep 12.
• Lim C, Tan HK, Kaushik M. Hypophosphatemia in critically ill patients with acute kidney injury treated with hemodialysis is associated with adverse events. Clin Kidney J. 2017 Jun;10(3):341-347. doi: 10.1093/ckj/sfw120. Epub 2017 Jan 5.
• Hendrix RJ, Hastings MC, Samarin M, Hudson JQ. Predictors of Hypophosphatemia and Outcomes during Continuous Renal Replacement Therapy. Blood Purif. 2020;49(6):700-707. doi: 10.1159/000507421. Epub 2020 Apr 22.
• Pasko DA, Mottes TA, Mueller BA. Pre dialysis of blood prime in continuous hemodialysis normalizes pH and electrolytes. Pediatr Nephrol. 2003 Nov;18(11):1177-83. doi: 10.1007/s00467-003-1258-2. Epub 2003 Oct 2.
• Yessayan L, Yee J, Frinak S, Szamosfalvi B. Continuous Renal Replacement Therapy for the Management of Acid-Base and Electrolyte Imbalances in Acute Kidney Injury. Adv Chronic Kidney Dis. 2016 May;23(3):203-10. doi: 10.1053/j.ackd.2016.02.005.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: April 18, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CRRT; Phosphate-containing replacement fluid
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Sepsis
• Other Study ID Numbers: A1805-PL-LC-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie the results reported in the final publication, after de-identification (including demographic data, baseline clinical characteristics, and primary/secondary efficacy and safety outcomes), will be made available for sharing. This includes the analytic data set, the study protocol, and the statistical analysis plan. Data will be shared with qualified researchers who provide a methodologically sound proposal and have obtained ethical approval from their respective institutions. The purpose of the data sharing must be for secondary analysis to foster scientific advancement in critical care nutrition and phosphorus homeostasis.
• IPD Sharing Time Frame: The IPD and supporting information will be available starting 6 months after the primary results are published in a peer-reviewed journal. The data will remain accessible for a period of 3 years following the initial publication to allow for secondary analyses.
• IPD Sharing Access Criteria: De-identified individual participant data will be available to qualified academic researchers who provide a methodologically sound research proposal that is approved by the study's steering committee. Data access will be granted for the purpose of achieving the aims in the approved proposal. To obtain access, requestors must sign a Data Access Agreement (DAA) to ensure participant privacy and data security. Requests should be directed to the corresponding author of the primary publication or the Central Contact listed in this registration.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No